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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® SurgiClose® - 05694310960700

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
In Commercial Distribution

  • 05694310960717 ()
  • 05694310960700 ()

  • Length: 7 Centimeter
  • Width: 10 Centimeter
50205S03D0D

  • Collagen wound matrix dressing

Kerecis® GraftGuide® - 05694310960656

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
In Commercial Distribution

  • 05694310960663 ()
  • 05694310960656 ()

  • Area/Surface Area: 250 Square centimeter
50202S24D0D

  • Collagen wound matrix dressing

Kerecis® Omega3 BURN - 05694310960564

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). Trapezoid Double Pouched https://www.kerecis.com/wp-content/uploads/2020/10/A5-KM-19-0146-IFU-Kerecis-Burn-US.pdf
KERECIS hf.
300cm2 Meshed Burn
In Commercial Distribution

  • 05694310960571 ()
  • 05694310960564 ()

  • Length: 7 Centimeter
  • Width: 7 Centimeter
50202S23D0D

  • Collagen wound matrix dressing

Kerecis® GraftGuide® - 05694310960540

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
In Commercial Distribution

  • 05694310960557 ()
  • 05694310960540 ()

  • Area/Surface Area: 300 Square centimeter
50202S23D0D

  • Collagen wound matrix dressing

Kerecis® GraftGuide® - 05694310960472

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.
7x7 cm Meshed
In Commercial Distribution

  • 05694310960472 ()
  • 05694310960489 ()

  • Length: 7 Centimeter
  • Width: 7 Centimeter
50202M04D0D

  • Collagen wound matrix dressing

Kerecis® Omega3 BURN - 05694310960458

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

  • 05694310960458 ()
  • 05694310960465 ()

  • Length: 7 Centimeter
  • Width: 10 Centimeter
50202M03D0D

  • Collagen wound matrix dressing

Kerecis® GraftGuide® - 05694310960434

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.
7x20 cm Meshed
In Commercial Distribution

  • 05694310960441 ()
  • 05694310960434 ()

  • Length: 7 Centimeter
  • Width: 20 Centimeter
50202M21D0D

  • Collagen wound matrix dressing

Kerecis® Omega3 BURN - 05694310960427

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.
10x25 Meshed Burn
In Commercial Distribution

  • 05694310960427 ()

  • Length: 10 Centimeter
  • Width: 25 Centimeter
50202M22D0D

  • Collagen wound matrix dressing

Kerecis® Omega3 BURN - 05694310960410

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). Double Pouched https://www.kerecis.com/wp-content/uploads/2020/10/A5-KM-19-0146-IFU-Kerecis-Burn-US.pdf
KERECIS hf.
10x25 Solid Burn
In Commercial Distribution

  • 05694310960410 ()

  • Length: 10 Centimeter
  • Width: 25 Centimeter
50202S22D0D

  • Collagen wound matrix dressing

Kerecis® GraftGuide® - 05694310960397

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.
7x7 cm
Not in Commercial Distribution

  • 05694310960403 ()
  • 05694310960397 ()

  • Length: 7 Centimeter
  • Width: 7 Centimeter
50202S04D0D

  • Collagen wound matrix dressing

Kerecis® GraftGuide® - 05694310960373

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
In Commercial Distribution

  • 05694310960380 ()
  • 05694310960373 ()

  • Length: 7 Centimeter
  • Width: 10 Centimeter
50202S03D0D

  • Collagen wound matrix dressing

Kerecis® GraftGuide® - 05694310960335

Kerecis® Omega3 GraftGuide™ 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.
7x20 cm
In Commercial Distribution

  • 05694310960366 ()
  • 05694310960335 ()

  • Length: 7 Centimeter
  • Width: 20 Centimeter
50202S21D0D

  • Collagen wound matrix dressing

Kerecis® Omega3 Wound - 05694310960328

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 Double Pouch https://www.kerecis.com/wp-content/uploads/2020/11/Instructions-for-Use-IFU.pdf
KERECIS hf.
7x20 Solid Wound
Not in Commercial Distribution

  • 05694310960328 ()

  • Width: 7 Centimeter
  • Length: 20 Centimeter
50200S21D0D

  • Collagen wound matrix dressing

Kerecis® MariGen™ - 05694310960311

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.
7x20 cm
Not in Commercial Distribution

  • 05694310960311 ()
  • 05694310960588 ()

  • Width: 7 Centimeter
  • Length: 20 Centimeter
50200S21B0D

  • Collagen wound matrix dressing

Kerecis® Omega3 Wound - 05694310960298

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 Meshed https://www.kerecis.com/wp-content/uploads/2020/11/Instructions-for-Use-IFU.pdf
KERECIS hf.
7x10 Meshed Wound
Not in Commercial Distribution

  • 05694310960304 ()
  • 05694310960298 ()

  • Width: 7 Centimeter
  • Length: 10 Centimeter
50200M03B0D

  • Collagen wound matrix dressing

Kerecis® Omega3 Wound - 05694310960274

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 Meshed https://www.kerecis.com/wp-content/uploads/2020/11/Instructions-for-Use-IFU.pdf
KERECIS hf.
7x7 Meshed Wound
Not in Commercial Distribution

  • 05694310960281 ()
  • 05694310960274 ()

  • Width: 7 Centimeter
  • Length: 7 Centimeter
50200M04B0D

  • Collagen wound matrix dressing

Kerecis® Omega3 Wound - 05694310960250

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 https://www.kerecis.com/wp-content/uploads/2020/11/Instructions-for-Use-IFU.pdf
KERECIS hf.
7x7 Fenestrated Wound
Not in Commercial Distribution

  • 05694310960267 ()
  • 05694310960250 ()

  • Width: 7 Centimeter
  • Length: 7 Centimeter
50200M04B0D

  • Collagen wound matrix dressing

Kerecis® MariGen™ - 05694310960236

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.
7x7 cm
In Commercial Distribution

  • 05694310960236 ()
  • 05694310960243 ()

  • Length: 7 Centimeter
  • Width: 7 Centimeter
50200S04B0D

  • Collagen wound matrix dressing

Kerecis® MariGen™ - 05694310960212

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.
7x10 cm Fenestrated
In Commercial Distribution

  • 05694310960229 ()
  • 05694310960212 ()

  • Width: 7 Centimeter
  • Length: 10 Centimeter
50200F03B0D

  • Collagen wound matrix dressing

Kerecis® MariGen™ - 05694310960199

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.
3x7 cm Fenestrated
In Commercial Distribution

  • 05694310960205 ()
  • 05694310960199 ()

  • Width: 3 Centimeter
  • Length: 7 Centimeter
50200F02B0D

  • Collagen wound matrix dressing

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
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