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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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Sterile-R
Dynarex Corporation
3096
In Commercial Distribution

  • 00840117343344 ()
  • 00840117343306 ()
  • 00840117343269 ()


  • Animal-derived wound matrix dressing
Sterile-R
Dynarex Corporation
3094
In Commercial Distribution

  • 00840117342347 ()
  • 00840117342330 ()
  • 00840117342323 ()


  • Animal-derived wound matrix dressing
Wound contact layer
Covalon Technologies Ltd
5550441
Not in Commercial Distribution

  • 00825439013489 ()
  • 00825439013472 ()
  • 10825439013493 ()

  • Length: 4 Inch
  • Width: 4 Inch


  • Animal-derived wound matrix dressing
Simpurity Collagen 7" x 7" Dressing
SAFE N' SIMPLE LLC
SNS52277
In Commercial Distribution

  • 00810040131875 ()
  • 20810040131879 ()
SNS52277

  • 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.
80 mm Circular
In Commercial Distribution

  • 05694310965224 ()
  • 05694310965217 ()
  • 05694310965231 ()

  • Outer Diameter: 80 Millimeter
50215L54B0D

  • Animal-derived wound matrix dressing
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

  • 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
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