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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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Kerecis® MariGen™ - 05694310960175

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.
3x3.5 cm Fenestrated
In Commercial Distribution

  • 05694310960182 ()
  • 05694310960175 ()

  • Width: 3 Centimeter
  • Length: 3.5 Centimeter
50200F01B0D

  • Collagen wound matrix dressing

Kerecis® MariGen™ - 05694310960151

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. https://www.kerecis.com/ifus/ifu-kerecis-marigen/
KERECIS hf.
16 mm Circular
In Commercial Distribution

  • 05694310960151 ()
  • 05694310960168 ()

  • Circumference: 16 Millimeter
50200S16B0D

  • Collagen wound matrix dressing

Kerecis® Omega3 Wound - 05694310960137

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 14 mm Circular https://www.kerecis.com/wp-content/uploads/2020/11/Instructions-for-Use-IFU.pdf
KERECIS hf.
14 mm Solid Circular Wound
Not in Commercial Distribution

  • 05694310960144 ()
  • 05694310960137 ()

  • Circumference: 14 Millimeter
50200S14B0D

  • Collagen wound matrix dressing

Kerecis® Wound - 05694310960113

Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® 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 https://www.kerecis.com/ifus/ifu-kerecis-omega3-marigen/
KERECIS hf.
12 mm Solid Circular Wound
Not in Commercial Distribution

  • 05694310960120 ()
  • 05694310960113 ()

  • Circumference: 12 Millimeter
50200S12B0D

  • Collagen wound matrix dressing

Kerecis® MariGen™ - 05694310960052

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. https://www.kerecis.com/ifus/ifu-kerecis-marigen/
KERECIS hf.
1.75x1.75 cm
In Commercial Distribution

  • 05694310960069 ()
  • 05694310960052 ()

  • Width: 1.75 Centimeter
  • Length: 1.75 Centimeter
50200S00B0D

  • Collagen wound matrix dressing

Kerecis® Omega3 BURN - 05694310960038

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). Meshed 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

  • 05694310960045 ()
  • 05694310960038 ()

  • Length: 7 Centimeter
  • Width: 20 Centimeter
50202M14B0D

  • Collagen wound matrix dressing

Kerecis® Omega3 BURN - 05694310960014

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). Meshed Double Pouched https://www.kerecis.com/wp-content/uploads/2020/10/A5-KM-19-0146-IFU-Kerecis-Burn-US.pdf
KERECIS hf.
7x10 Meshed Burn
In Commercial Distribution

  • 05694310960021 ()
  • 05694310960014 ()

  • Length: 7 Centimeter
  • Width: 10 Centimeter
50202M13B0D

  • Collagen wound matrix dressing

Kerecis® Shield® Adhesive - 05694310965187

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.
15mm Circular
In Commercial Distribution

  • 05694310965194 ()
  • 05694310965187 ()
  • 05694310965200 ()

  • Outer Diameter: 15 Millimeter
50215H50B0D

  • Collagen wound matrix dressing

Kerecis® Omega3 BURN - 05694310960670

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). Pentagon Meshed Double Pouched https://www.kerecis.com/wp-content/uploads/2020/10/A5-KM-19-0146-IFU-Kerecis-Burn-US.pdf
KERECIS hf.
250cm2 Meshed Burn
In Commercial Distribution

  • 05694310960670 ()
  • 05694310960687 ()

  • Length: 250 Centimeter
  • Width: 250 Centimeter
50202M24D0D

  • Collagen wound matrix dressing

Lineum® OCT - 00880304983816

No Description
BIOMET SPINE LLC
14-524038E
In Commercial Distribution

  • 00880304983816 ()

  • HF Plug
14-524038E

  • Bone-screw internal spinal fixation system, sterile

RadQual - 00850020470259

Co 60 Syringe
RADQUAL, LLC
BM06S-60
In Commercial Distribution

  • 00850020470259 ()


  • Radionuclide source, quality assurance

Vital Signs - 10885403256998

CAPNOSTAT CO Sensor
Carefusion Finland 320 Oy
412340-002
Not in Commercial Distribution

  • 10885403256998 ()
412340-002

  • Carbon dioxide sensor/cable

ACUMED - 10806378074547

CO/CA Countersink
Acumed LLC
PL-2080
In Commercial Distribution

  • 10806378074547 ()


  • Surgical countersink, reusable

Merlin.net - 05414734510035

HF Portal
CARDIOMEMS, INC.
MN6000
In Commercial Distribution

  • 05414734510035 ()
MN6000

  • Implantable pulmonary artery pressure monitoring system

FlowTube HF - 04048223032503

FlowTube HF
Pajunk GmbH Medizintechnologie
1299-00-16
Not in Commercial Distribution

  • 04048223032503 ()
1299-00-16

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

FlowTube HF - 04048223028148

FlowTube HF
Pajunk GmbH Medizintechnologie
1299-00-24
Not in Commercial Distribution

  • 04048223028148 ()
1299-00-24

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

FlowTube HF - 04048223006764

FlowTube HF
Pajunk GmbH Medizintechnologie
1299-00-15
Not in Commercial Distribution

  • 04048223006764 ()
1299-00-15

  • Haemostatic knife

HF - 06971519616782

No Description
Anji Hengfeng Sanitary Material Co., Ltd
HFFAB1-6
In Commercial Distribution

  • 06971519616782 ()


  • First aid absorbent pad/bandage

HF - 06971519616645

No Description
Anji Hengfeng Sanitary Material Co., Ltd
HFFAB1-5
In Commercial Distribution

  • 06971519616645 ()


  • First aid absorbent pad/bandage

HF - 06971519616614

No Description
Anji Hengfeng Sanitary Material Co., Ltd
HFCG02
In Commercial Distribution

  • 06971519616614 ()


  • Pressure bandage, non-latex, single-use

HF - 06971519616591

No Description
Anji Hengfeng Sanitary Material Co., Ltd
HFFAB1-3
In Commercial Distribution

  • 06971519616591 ()


  • First aid absorbent pad/bandage

HF - 06971519616584

No Description
Anji Hengfeng Sanitary Material Co., Ltd
HFFAB1-2
In Commercial Distribution

  • 06971519616584 ()


  • First aid absorbent pad/bandage

HF - 06971519616577

No Description
Anji Hengfeng Sanitary Material Co., Ltd
HFFAB1-1
In Commercial Distribution

  • 06971519616577 ()


  • First aid absorbent pad/bandage

HF - 06971519614139

No Description
Anji Hengfeng Sanitary Material Co., Ltd
HFCG01
In Commercial Distribution

  • 16971519614136 ()
  • 06971519614139 ()


  • Pressure bandage, non-latex, single-use

HF - 06971519614030

No Description
Anji Hengfeng Sanitary Material Co., Ltd
HFFAB1-7
In Commercial Distribution

  • 06971519614030 ()


  • First aid absorbent pad/bandage

HF - 06971519610049

No Description
Anji Hengfeng Sanitary Material Co., Ltd
HFEB03
In Commercial Distribution

  • 06971519610049 ()
  • 26971519610043 ()


  • Pressure bandage, non-latex, single-use

ECG Acquisition Systems - 06970366110023

No Description
VALES & HILLS BIOMEDICAL TECH. LTD.
iCV200S
In Commercial Distribution

  • 06970366110023 ()


  • Electrocardiograph, professional, multichannel

ECG Acquisition Systems - 06970366110016

No Description
VALES & HILLS BIOMEDICAL TECH. LTD.
iCV200(BLE)
In Commercial Distribution

  • 06970366110016 ()


  • Electrocardiograph, professional, multichannel

ACQUISITION MODULE CABLE - 00841034110804

No Description
RPI
GEC021
In Commercial Distribution

  • 00841034110804 ()
GEC021

  • Electrocardiographic lead set, reusable

ACQUISITION MODULE CABLE - 00841034110798

No Description
RPI
GEC020
In Commercial Distribution

  • 00841034110798 ()
GEC020

  • Electrocardiographic lead set, reusable

MapRT acquisition software - 05056190500757

MapRT is used to assist treatment planning whereby the patient surface and positioning devices captured at simulation can be modelled against the treatment devices, such that any potential collisions can be predicted.
VISION RT LIMITED
MapRT acquisition software
In Commercial Distribution

  • 05056190500757 ()
MapRT

  • Radiation therapy software

KING Acquisition Cable - 00663427000413

KING Acquisition Cable 4 Female 1.5 mm TP Connectors (Red X 2, Green, Black) to 3 Alligator Clips (Red X2,/Green) 1 Male Shrouded TP Connector, Black Length 48” (122 cm)
Kego Corporation
KM-PA051348TC
In Commercial Distribution

  • 00663427000413 ()


  • Electrocardiographic lead set, reusable

TruScan Neurofeedback Acquisition - 08592566509001

50-900
DEYMED Diagnostic s.r.o.
50-900
In Commercial Distribution

  • 08592566509001 ()
50-900

  • Psychophysiological biofeedback system

LINEUM OCT SPINE SYSTEM - 00888480488002

No Description
BIOMET SPINE LLC
14-524038
In Commercial Distribution

  • 00888480488002 ()

  • LINEUM HF PLUG
14-524038

  • Bone-screw internal spinal fixation system, non-sterile

LINEUM OCT SPINE SYSTEM - 00888480580898

No Description
BIOMET SPINE LLC
14-524038E
In Commercial Distribution

  • 00888480580898 ()

  • LINEUM HF PLUG
14-524038E

  • Bone-screw internal spinal fixation system, sterile

Lineum® OCT Spine System - 00880304959910

No Description
BIOMET SPINE LLC
14-524038
In Commercial Distribution

  • 00880304959910 ()

  • LINEUM HF PLUG
14-524038

  • Bone-screw internal spinal fixation system, non-sterile

Lineum® OCT - 00880304983854

No Description
BIOMET SPINE LLC
14-524045E
In Commercial Distribution

  • 00880304983854 ()

  • Occipital HF Plug
14-524045E

  • Bone-screw internal spinal fixation system, sterile

CoMatryx Surgical Bovine Type 1 Collagen 2.5mL - 00366977010252

Co Matryx collagen product
Mpm Medical, LLC
1
In Commercial Distribution

  • 00366977010252 ()

  • Total Volume: 2.5 Milliliter
COM10

  • Collagen wound matrix dressing

TruLink - 10841522124679

CABLE ASSEMBLY,ADAPTER,CO
SPACELABS HEALTHCARE (WASHINGTON), INC
ECG Cables & Leadwires
In Commercial Distribution

  • 10841522124679 ()
700-1027-00

  • Electrical-only medical device connection cable, reusable

Trulink - 10841522122613

CABLE ASSEMBLY,ADAPTOR,CO
SPACELABS HEALTHCARE (WASHINGTON), INC
Adapter Cables
In Commercial Distribution

  • 10841522122613 ()

  • 30 cm/12" Length
700-0027-00

  • Patient monitoring system module, multifunction
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