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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). 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

  • Animal-derived wound matrix dressing
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

  • Animal-derived wound matrix dressing
Bilayer wound management medical device product made from fish skin and silicone. Kerecis® SurgiClose® 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-surgiclose-silicone/
KERECIS hf.
10 x 18 cm fish skin
In Commercial Distribution

  • 05694310965170 ()
  • 05694310965163 ()

  • Height: 10 Centimeter
  • Width: 18 Centimeter
50214F56D0D

  • Animal-derived wound matrix dressing
Bilayer wound management medical device product made from fish skin and silicone. Kerecis® SurgiClose® 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-surgiclose-silicone/
KERECIS hf.
6 x 14 cm fish skin
In Commercial Distribution

  • 05694310965156 ()
  • 05694310965149 ()

  • Width: 14 Centimeter
  • Height: 6 Centimeter
50214F55D0D

  • Animal-derived wound matrix dressing
No Description
KERECIS hf.
Expanse 4x4 cm
In Commercial Distribution

  • 05694310964517 ()
  • 05694310964500 ()

  • Width: 4 Centimeter
  • Length: 3 Centimeter
50200N44B0D

  • 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.
Expanse 3x3 cm
In Commercial Distribution

  • 05694310964494 ()
  • 05694310964487 ()

  • Length: 3 Centimeter
  • Width: 3 Centimeter
50200N43B0D

  • 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.
Expanse 2x2 cm
In Commercial Distribution

  • 05694310964470 ()
  • 05694310964463 ()

  • Length: 2 Centimeter
  • Width: 2 Centimeter
50200N42B0D

  • Animal-derived wound matrix dressing
Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Spiral 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.
Diameter: 30mm
In Commercial Distribution

  • 05694310964371 ()
  • 05694310964364 ()

  • Outer Diameter: 30 Millimeter
50215K52B0D

  • Animal-derived wound matrix dressing
Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Standard 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.
Diameter: 50mm
In Commercial Distribution

  • 05694310964326 ()
  • 05694310964319 ()

  • Outer Diameter: 50 Millimeter
50215I53B0D

  • Animal-derived wound matrix dressing
Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide™ Mano 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-omega3-graftguide/
KERECIS hf.
Size L, 196 sq cm Dorsum Right / Palmar Left Meshed 2:1
In Commercial Distribution

  • 05694310964029 ()
  • 05694310964012 ()

  • Area/Surface Area: 196 Square centimeter
50202N36D0D

  • Animal-derived wound matrix dressing
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