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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® - 05694310960724

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
In Commercial Distribution

  • 05694310960724 ()
  • 05694310960731 ()

  • Length: 7 Centimeter
  • Width: 20 Centimeter
50205S21D0D

  • Collagen wound matrix dressing

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 - 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 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
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