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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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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

  • Animal-derived wound matrix dressing
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

  • Animal-derived wound matrix dressing
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

  • Animal-derived wound matrix dressing
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

  • Animal-derived wound matrix dressing
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

  • Animal-derived wound matrix dressing
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

  • Animal-derived wound matrix dressing
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

  • Animal-derived wound matrix dressing
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

  • Animal-derived wound matrix dressing
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

  • Animal-derived wound matrix dressing
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

  • Animal-derived wound matrix dressing
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