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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Precise TypeTM HEA BeadCheck Kit - 10888234102632

No Description
BIOARRAY SOLUTIONS LTD
800-20236
In Commercial Distribution

  • 10888234102632 ()
800-20236

  • Multiple blood group genotyping IVD, control

Immucor Precise TypeTM Human Erythrocyte Antigen Molecular BeadChip Test Plate - 10888234102618

No Description
BIOARRAY SOLUTIONS LTD
800-20202-96
In Commercial Distribution

  • 10888234102618 ()
800-20202-96

  • Multiple blood group genotyping IVD, nucleic acid technique (NAT)

BeadCheck HEA Ref-pB, Bulk and Fill - 10888234102328

No Description
BIOARRAY SOLUTIONS LTD
800-00229
In Commercial Distribution

  • 10888234102328 ()
800-00229

  • Multiple blood group genotyping IVD, control

BeadCheck HEA Ref-pA, Bulk and Fill - 10888234102298

No Description
BIOARRAY SOLUTIONS LTD
800-00228
In Commercial Distribution

  • 10888234102298 ()
800-00228

  • Multiple blood group genotyping IVD, control

Hemo-QC - 00858352006009

Hemo-QC simulates blood samples and is intended for the daily quality control of routine blood bank reagents used in manual, semi-automated and automated blood typing and antibody screen test systems.
HEMO BIOSCIENCE INC
H9200
In Commercial Distribution

  • 00858352006009 ()
H9200

  • Multiple blood group genotyping IVD, control

ID CORE CONTROL - 08437013457040

The ID CORE CONTROL kit consists of 2 sets of recombinant synthetic DNA plasmids to be used as positive controls to evaluate the performance of the ID CORE XT test(Kit Product Number: 1021720000). The ID CORE CONTROL kit contains two separate vials: ID CORE CONTROL 1 and ID CORE CONTROL 2, both composed of synthetic plasmid pools to be used as assayed positive controls for alternate alleles (alleles 1 and 2, respectively) of the 29 polymorphisms assayed by ID CORE XT. Both control vials must be used in every run of the ID CORE XT test as positive controls for the correct detection of the polymorphism genotypes interrogated by the test. Each control has expected polymorphism genotypes results in the ID CORE XT test when analyzed by the ID CORE XT ANALYSIS SOFTWARE and will produce a valid or invalid run result. ID CORE XT is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in human genomic DNA. ID CORE XT interrogates 29 polymorphisms to predict 53 HEA allele genotypes and 37 antigen phenotypes of the following blood group systems: Rh, Kell, Kidd, Duffy, MNS, Diego, Dombrock, Colton, Cartwright and Lutheran, as an alternative to serology.
PROGENIKA BIOPHARMA, SA
v1
In Commercial Distribution

  • 08437013457040 ()
1301790000

  • Multiple blood group genotyping IVD, control

ID CORE XT - 08437013457019

ID CORE XT (Reagents and Analysis Software) is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in genomic DNA extracted from whole blood specimens collected in EDTA. This test can be used to genotype 29 polymorphisms and predict 37 HEA phenotypes of blood group systems Rh (CW, C, c, E, e, VS, V, hrB, hrS), Kell (K, k, Kpa, Kpb, Jsa, Jsb), Kidd (Jka, Jkb), Duffy (Fya, Fyb), MNS (M, N, S, s, U, Mia), Diego (Dia, Dib), Dombrock (Doa, Dob, Hy, Joa), Colton (Coa, Cob), Cartwright (Yta, Ytb), and Lutheran (Lua, Lub) as an alternative to serology. The ID CORE XT test relies on allele-specific probes attached to color-coded microspheres, which hybridize specifically to the labeled PCR products. A subsequent fluorescent labeling step allows detection and quantification of the hybridization signal. ID CORE XT generates a simultaneous multiplex reaction in a single well, avoiding the need to run separate methods in parallel. The software outcome is a polymorphism genotype, a predicted allele genotype and a predicted phenotype, bypassing any subjective interpretation of the results.
PROGENIKA BIOPHARMA, SA
v3
In Commercial Distribution

  • 08437013457019 ()
1021720000

  • Multiple blood group genotyping IVD, nucleic acid technique (NAT)

Filled Vial,HotStarTaq DNA Polymerase - 10888234100928

No Description
BIOARRAY SOLUTIONS LTD
800-10242
In Commercial Distribution

  • 10888234100928 ()
800-10242

  • Multiple blood group genotyping IVD, reagent

Filled Vial,Negative Control 1mL - 10888234100836

No Description
BIOARRAY SOLUTIONS LTD
800-00287
In Commercial Distribution

  • 10888234100836 ()
800-00287

  • Multiple blood group genotyping IVD, reagent

Filled Vial, Lambda Exonuclease - 10888234100683

No Description
BIOARRAY SOLUTIONS LTD
800-00195
In Commercial Distribution

  • 10888234100683 ()
800-00195

  • Multiple blood group genotyping IVD, reagent

Filled Vial, HEA 1.2 PCR Mix - 10888234100669

No Description
BIOARRAY SOLUTIONS LTD
800-00194
In Commercial Distribution

  • 10888234100669 ()
800-00194

  • Multiple blood group genotyping IVD, reagent

Filled Vial, eMAPTM Elongation Mix - 10888234100645

No Description
BIOARRAY SOLUTIONS LTD
800-00193
In Commercial Distribution

  • 10888234100645 ()
800-00193

  • Multiple blood group genotyping IVD, reagent

Filled Vial, Clean-up, 330uL - 10888234100621

No Description
BIOARRAY SOLUTIONS LTD
800-00191
In Commercial Distribution

  • 10888234100621 ()
800-00191

  • Multiple blood group genotyping IVD, reagent

Galeo Pro - 00814384020192

Coronary Guidewire
CONCERT MEDICAL, LLC
HF
In Commercial Distribution

  • 00814384020192 ()
  • 00814384020185 ()
389781

  • Cardiac/peripheral vascular guidewire, single-use

Galeo HYDRO - 00814384020116

Coronary Guidewire
CONCERT MEDICAL, LLC
HF
In Commercial Distribution

  • 00814384020116 ()
  • 00814384020109 ()
406891

  • Cardiac/peripheral vascular guidewire, single-use

Galeo - 00814384020017

Coronary Guidewire
CONCERT MEDICAL, LLC
HF
In Commercial Distribution

  • 00814384020017 ()
  • 00814384020000 ()
406886

  • Cardiac/peripheral vascular guidewire, single-use

Kerecis® SurgiClose® Silicone - 05694310965163

Bilayer wound management medical device product made from fish skin and silicone. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-surgiclose-silicone/
KERECIS hf.
10 x 18 cm fish skin
In Commercial Distribution

  • 05694310965170 ()
  • 05694310965163 ()

  • Height: 10 Centimeter
  • Width: 18 Centimeter
50214F56D0D

  • Collagen wound matrix dressing

Kerecis® SurgiClose® Silicone - 05694310965149

Bilayer wound management medical device product made from fish skin and silicone. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-surgiclose-silicone/
KERECIS hf.
6 x 14 cm fish skin
In Commercial Distribution

  • 05694310965156 ()
  • 05694310965149 ()

  • Width: 14 Centimeter
  • Height: 6 Centimeter
50214F55D0D

  • Collagen wound matrix dressing

Kerecis® MariGen™ - 05694310964500

No Description
KERECIS hf.
Expanse 4x4 cm
In Commercial Distribution

  • 05694310964517 ()
  • 05694310964500 ()

  • Width: 4 Centimeter
  • Length: 3 Centimeter
50200N44B0D

  • Collagen wound matrix dressing

Kerecis® MariGen™ - 05694310964487

Fish-skin graft for wound management. Kerecis® MariGen™ is indicated for the management of wounds including: Partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-marigen/
KERECIS hf.
Expanse 3x3 cm
In Commercial Distribution

  • 05694310964494 ()
  • 05694310964487 ()

  • Length: 3 Centimeter
  • Width: 3 Centimeter
50200N43B0D

  • Collagen wound matrix dressing

Kerecis® MariGen™ - 05694310964463

Fish-skin graft for wound management. Kerecis® MariGen™ is indicated for the management of wounds including: Partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-marigen/
KERECIS hf.
Expanse 2x2 cm
In Commercial Distribution

  • 05694310964470 ()
  • 05694310964463 ()

  • Length: 2 Centimeter
  • Width: 2 Centimeter
50200N42B0D

  • Collagen wound matrix dressing

Kerecis® Shield™ Spiral - 05694310964364

Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Spiral is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-shield/
KERECIS hf.
Diameter: 30mm
In Commercial Distribution

  • 05694310964371 ()
  • 05694310964364 ()

  • Outer Diameter: 30 Millimeter
50215K52B0D

  • Collagen wound matrix dressing

Kerecis® Shield™ Standard - 05694310964319

Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Standard is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-shield/
KERECIS hf.
Diameter: 50mm
In Commercial Distribution

  • 05694310964326 ()
  • 05694310964319 ()

  • Outer Diameter: 50 Millimeter
50215I53B0D

  • Collagen wound matrix dressing

Kerecis® GraftGuide™ Mano - 05694310964012

Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide™ Mano is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts. IFU: https://www.kerecis.com/ifus/ifu-kerecis-omega3-graftguide/
KERECIS hf.
Size L, 196 sq cm Dorsum Right / Palmar Left Meshed 2:1
In Commercial Distribution

  • 05694310964029 ()
  • 05694310964012 ()

  • Area/Surface Area: 196 Square centimeter
50202N36D0D

  • Collagen wound matrix dressing

Kerecis® GraftGuide™ Mano - 05694310963992

Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide™ Mano is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts. IFU: https://www.kerecis.com/ifus/ifu-kerecis-omega3-graftguide/
KERECIS hf.
Size L, 196 sq cm Dorsum Left / Palmar Right Meshed 2:1
In Commercial Distribution

  • 05694310964005 ()
  • 05694310963992 ()

  • Area/Surface Area: 196 Square centimeter
50202N35D0D

  • Collagen wound matrix dressing

Kerecis® GraftGuide™ Mano - 05694310963978

Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide™ Mano is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts. IFU: https://www.kerecis.com/ifus/ifu-kerecis-omega3-graftguide/
KERECIS hf.
Size M, 147 sq cm Dorsum Right / Palmar Left Meshed 2:1
In Commercial Distribution

  • 05694310963985 ()
  • 05694310963978 ()

  • Area/Surface Area: 147 Square centimeter
50202N34D0D

  • Collagen wound matrix dressing

Kerecis® GraftGuide™ Mano - 05694310963954

Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide™ Mano is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts. IFU: https://www.kerecis.com/ifus/ifu-kerecis-omega3-graftguide/
KERECIS hf.
Size M, 147 sq cm Dorsum Left / Palmar Right Meshed 2:1
In Commercial Distribution

  • 05694310963954 ()
  • 05694310963961 ()

  • Area/Surface Area: 147 Square centimeter
50202N33D0D

  • Collagen wound matrix dressing

Kerecis® GraftGuide® - 05694310963930

Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide® is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts. IFU: https://www.kerecis.com/ifus/ifu-kerecis-graftguide/
KERECIS hf.
Micro 114 sq cm
In Commercial Distribution

  • 05694310963947 ()
  • 05694310963930 ()

  • Area/Surface Area: 114 Square centimeter
50202P32D0D

  • Collagen wound matrix dressing

Kerecis® SurgiClose® - 05694310963916

Fish-Skin Graft for Surgical Use. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full thickness wounds, pressure ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor site/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgiclose/
KERECIS hf.
Micro 95 sq cm
In Commercial Distribution

  • 05694310963923 ()
  • 05694310963916 ()

  • Area/Surface Area: 95 Square centimeter
50205P31D0D

  • Collagen wound matrix dressing

Kerecis® SurgiClose® - 05694310963893

Fish-Skin Graft for Surgical Use. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full thickness wounds, pressure ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor site/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgiclose/
KERECIS hf.
6x8 cm
In Commercial Distribution

  • 05694310963909 ()
  • 05694310963893 ()

  • Width: 6 Centimeter
  • Length: 8 Centimeter
50205S18D0D

  • Collagen wound matrix dressing

Kerecis® SurgiClose® - 05694310963879

Fish-Skin Graft for Surgical Use. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full thickness wounds, pressure ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor site/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgiclose/
KERECIS hf.
6x8 cm Meshed 2:1
In Commercial Distribution

  • 05694310963886 ()
  • 05694310963879 ()

  • Length: 6 Centimeter
  • Width: 4 Centimeter
50205N18D0D

  • Collagen wound matrix dressing

Kerecis® SurgiClose® - 05694310963855

Fish-Skin Graft for Surgical Use. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full thickness wounds, pressure ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor site/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgiclose/
KERECIS hf.
4x6 cm
In Commercial Distribution

  • 05694310963862 ()
  • 05694310963855 ()

  • Width: 4 Centimeter
  • Length: 6 Centimeter
50205S20D0D

  • Collagen wound matrix dressing

Kerecis® SurgiClose® - 05694310963831

Fish-Skin Graft for Surgical Use. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full thickness wounds, pressure ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor site/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgiclose/
KERECIS hf.
4x6 cm Meshed 2:1
In Commercial Distribution

  • 05694310963848 ()
  • 05694310963831 ()

  • Width: 6 Centimeter
  • Length: 8 Centimeter
50205N20D0D

  • Collagen wound matrix dressing

Kerecis® SurgiBind™ - 05694310963794

Fish skin for surgical use. INTENDED USE Kerecis® SurgiBind™ is indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgibind/
KERECIS hf.
3x20 cm
In Commercial Distribution

  • 05694310963800 ()
  • 05694310963794 ()

  • Width: 3 Centimeter
  • Length: 20 Centimeter
50241S19D0D

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

Kerecis® Shield™ Adhesive - 05694310963770

Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Adhesive is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-shield/
KERECIS hf.
30 mm Circular
In Commercial Distribution

  • 05694310963787 ()
  • 05694310963770 ()

  • Outer Diameter: 30 Millimeter
50215I52B0D

  • Collagen wound matrix dressing

Kerecis® Shield™ Adhesive - 05694310963756

Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Adhesive is indicated for the management of wounds including: Partial and full-thickness wounds, Pressure ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (abrasions, lacerations, partial-thickness burns, skin tears), Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and Draining wounds. https://www.kerecis.com/ifus/ifu-kerecis-shield/
KERECIS hf.
20 mm Circular
In Commercial Distribution

  • 05694310963763 ()
  • 05694310963756 ()

  • Outer Diameter: 20 Millimeter
50215H51B0D

  • Collagen wound matrix dressing

Kerecis® SurgiClose® - 05694310961554

Fish-Skin Graft for Surgical Use. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full thickness wounds, pressure ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor site/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgiclose/
KERECIS hf.
Micro 38 sq cm
In Commercial Distribution

  • 05694310961554 ()
  • 05694310961561 ()

  • Area/Surface Area: 38 Square centimeter
50205P04D0D

  • Collagen wound matrix dressing

Kerecis® SurgiClose® - 05694310961530

Fish-Skin Graft for Surgical Use. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full thickness wounds, pressure ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor site/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgiclose/
KERECIS hf.
Micro 19 sq cm
In Commercial Distribution

  • 05694310961547 ()
  • 05694310961530 ()

  • Area/Surface Area: 19 Square centimeter
50205P02D0D

  • Collagen wound matrix dressing

Kerecis® SurgiClose® - 05694310961493

Fish-Skin Graft for Surgical Use. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full thickness wounds, pressure ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor site/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgiclose/
KERECIS hf.
Micro 19 sq cm
Not in Commercial Distribution

  • 05694310961509 ()
  • 05694310961493 ()

  • Area/Surface Area: 19 Square centimeter
50205P02D0D

  • Collagen wound matrix dressing

Kerecis® SurgiClose® - 05694310961158

Fish-Skin Graft for Surgical Use. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full thickness wounds, pressure ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor site/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgiclose/
KERECIS hf.
7x20 cm Meshed 2:1
In Commercial Distribution

  • 05694310961165 ()
  • 05694310961158 ()

  • Length: 7 Centimeter
  • Width: 20 Centimeter
50205N21D0D

  • Collagen wound matrix dressing

Kerecis® SurgiClose® - 05694310961134

Fish-Skin Graft for Surgical Use. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full thickness wounds, pressure ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor site/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgiclose/
KERECIS hf.
7x10 cm Meshed 2:1
In Commercial Distribution

  • 05694310961141 ()
  • 05694310961134 ()

  • Length: 7 Centimeter
  • Width: 10 Centimeter
50205N03D0D

  • Collagen wound matrix dressing

Kerecis® Omega3 BURN - 05694310961110

Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Burn is indicated for the management of wounds including: - Partial and full-thickness wounds, - Trauma wounds (abrasions, lacerations, second-degree burns, skin tears). Mesh ratio 2:1 Double Pouched https://www.kerecis.com/wp-content/uploads/2020/10/A5-KM-19-0146-IFU-Kerecis-Burn-US.pdf
KERECIS hf.
7x20 Meshed Burn
In Commercial Distribution

  • 05694310961127 ()
  • 05694310961110 ()

  • Length: 7 Centimeter
  • Width: 20 Centimeter
50202N21D0D

  • Collagen wound matrix dressing

Kerecis® GraftGuide® - 05694310961097

Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide® is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts. IFU: https://www.kerecis.com/ifus/ifu-kerecis-graftguide/
KERECIS hf.
7x10 cm Meshed
In Commercial Distribution

  • 05694310961103 ()
  • 05694310961097 ()

  • Length: 7 Centimeter
  • Width: 10 Centimeter
50202N03D0D

  • Collagen wound matrix dressing

Kerecis® SurgiClose® - 05694310961059

Fish-Skin Graft for Surgical Use. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full thickness wounds, pressure ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor site/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgiclose/
KERECIS hf.
300 sq cm Meshed 2:1
In Commercial Distribution

  • 05694310961066 ()
  • 05694310961059 ()

  • Area/Surface Area: 300 Square centimeter
50205N23D0D

  • Collagen wound matrix dressing

Kerecis® SurgiClose® - 05694310961035

Fish-Skin Graft for Surgical Use. Kerecis® SurgiClose® is indicated for the management of wounds including: Partial and full thickness wounds, pressure ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor site/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgiclose/
KERECIS hf.
250 sq cm Meshed 2:1
In Commercial Distribution

  • 05694310961042 ()
  • 05694310961035 ()

  • Area/Surface Area: 250 Square centimeter
50205N24D0D

  • Collagen wound matrix dressing

Kerecis® GraftGuide® - 05694310961011

Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide® is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts. IFU: https://www.kerecis.com/ifus/ifu-kerecis-graftguide/
KERECIS hf.
300 sq cm Meshed
In Commercial Distribution

  • 05694310961028 ()
  • 05694310961011 ()

  • Area/Surface Area: 300 Square centimeter
50202N23D0D

  • Collagen wound matrix dressing

Kerecis® GraftGuide® - 05694310960991

Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide® is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts. IFU: https://www.kerecis.com/ifus/ifu-kerecis-graftguide/
KERECIS hf.
250 sq cm Meshed
In Commercial Distribution

  • 05694310961004 ()
  • 05694310960991 ()

  • Area/Surface Area: 250 Square centimeter
50202N24D0D

  • Collagen wound matrix dressing

Kerecis® Omega3 Wound - 05694310960977

"Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is indicated for the management of wounds including: •Partial and full-thickness wounds •Pressure ulcers •Venous ulcers •Chronic vascular ulcers •Diabetic ulcers •Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) •Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) •Draining Wounds Particularized, double pouch https://www.kerecis.com/wp-content/uploads/2020/11/Instructions-for-Use-IFU.pdf"
KERECIS hf.
7x7 Particularized Wound
Not in Commercial Distribution

  • 05694310960977 ()

  • Width: 7 Centimeter
  • Length: 7 Centimeter
50200P04D0D

  • Collagen wound matrix dressing

Kerecis® Omega3 Wound - 05694310960953

"Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is indicated for the management of wounds including: •Partial and full-thickness wounds •Pressure ulcers •Venous ulcers •Chronic vascular ulcers •Diabetic ulcers •Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) •Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) •Draining Wounds Particularized, double pouch https://www.kerecis.com/wp-content/uploads/2020/11/Instructions-for-Use-IFU.pdf"
KERECIS hf.
3x7 Fragmented Wound
Not in Commercial Distribution

  • 05694310960960 ()
  • 05694310960953 ()

  • Width: 3 Centimeter
  • Length: 7 Centimeter
50200P02D0D

  • Collagen wound matrix dressing

Kerecis® Omega3 Wound - 05694310960939

Acellular fish skin for topical and surgical wounds. "Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is indicated for the management of wounds including: •Partial and full-thickness wounds •Pressure ulcers •Venous ulcers •Chronic vascular ulcers •Diabetic ulcers •Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) •Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) •Draining Wounds Particularized, double pouch https://www.kerecis.com/wp-content/uploads/2020/11/Instructions-for-Use-IFU.pdf"
KERECIS hf.
3x3.5 Particularized Wound
Not in Commercial Distribution

  • 05694310960939 ()

  • Width: 3 Centimeter
  • Length: 3.5 Centimeter
50200P01D0D

  • Collagen wound matrix dressing
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