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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® GraftGuide® - 05694310960434

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 Meshed
In Commercial Distribution

  • 05694310960441 ()
  • 05694310960434 ()

  • Length: 7 Centimeter
  • Width: 20 Centimeter
50202M21D0D

  • Animal-derived wound matrix dressing

Kerecis® GraftGuide® - 05694310960335

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

Kerecis® Omega3 Wound - 05694310960328

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

Kerecis® MariGen™ - 05694310960311

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

Kerecis® Omega3 BURN - 05694310960038

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

neoplug - 00813954022093

Collagen Dental Wound Dressing
COLLAGEN MATRIX, INC.
neoplug
In Commercial Distribution

  • 10813954022090 ()
  • 00813954022093 ()

  • Length: 20 Millimeter
  • Width: 10 Millimeter


  • General oral wound dressing, animal-derived

CovaWound Alginate Ag 10x20cm - 00825439012185

Alginate dressing with silver
Covalon Technologies Ltd
3101020
In Commercial Distribution

  • 00825439012192 ()
  • 00825439012185 ()
  • 10825439012243 ()

  • Length: 20 Centimeter
  • Width: 10 Centimeter


  • Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

SurgiClear 6x20 - 00825439010426

Antimicrobial clear silicone adhesive dressing
Covalon Technologies Ltd
TWBD1023
In Commercial Distribution

  • 00825439010396 ()
  • 00825439010426 ()
  • 10825439010393 ()

  • Length: 20 Centimeter
  • Width: 6 Centimeter


  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive

GIBSON HEALTHCARE - 00366975012746

No Description
BENCO DENTAL SUPPLY CO.
5251-256
In Commercial Distribution

  • 00366975012746 ()

  • Length: 10 Millimeter
  • Width: 20 Millimeter


  • General oral wound dressing, animal-derived

GIBSON HEALTHCARE - 00366975012739

No Description
BENCO DENTAL SUPPLY CO.
5251-247
In Commercial Distribution

  • 00366975012739 ()

  • Length: 20 Millimeter
  • Width: 40 Millimeter


  • General oral wound dressing, animal-derived
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