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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™ - 05694310961653

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.
Micro 38 sq cm
In Commercial Distribution

  • 05694310961660 ()
  • 05694310961653 ()

  • Area/Surface Area: 38 Square centimeter
50200P04D0D

  • Collagen wound matrix dressing

Kerecis® MariGen™ - 05694310961615

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.
Micro 19 sq cm
In Commercial Distribution

  • 05694310961622 ()
  • 05694310961615 ()

  • Area/Surface Area: 19 Square centimeter
50200P02D0D

  • Collagen wound matrix dressing

Kerecis® MariGen™ - 05694310961592

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.
Micro 8 sq cm
In Commercial Distribution

  • 05694310961608 ()
  • 05694310961592 ()

  • Area/Surface Area: 8 Square centimeter
50200P01B0D

  • Collagen wound matrix dressing

Kerecis® MariGen™ - 05694310961578

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.
Micro 4 sq cm
In Commercial Distribution

  • 05694310961578 ()
  • 05694310961585 ()

  • Area/Surface Area: 4 Square centimeter
50200P00B0D

  • 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® MariGen™ - 05694310960892

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.
5x7 cm
In Commercial Distribution

  • 05694310960908 ()
  • 05694310960892 ()

  • Length: 5 Centimeter
  • Width: 7 Centimeter
50200S05B0D

  • 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
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