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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. "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.
3x3.5 Particularized Wound
Not in Commercial Distribution

  • 05694310960939 ()

  • Width: 3 Centimeter
  • Length: 3.5 Centimeter
50200P01D0D

  • Animal-derived wound matrix dressing
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.
10x25 cm
Not in Commercial Distribution

  • 05694310960748 ()

  • Length: 10 Centimeter
  • Width: 25 Centimeter
50205S22D0D

  • 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.
10x25 Meshed Burn
In Commercial Distribution

  • 05694310960427 ()

  • Length: 10 Centimeter
  • Width: 25 Centimeter
50202M22D0D

  • 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). Double Pouched https://www.kerecis.com/wp-content/uploads/2020/10/A5-KM-19-0146-IFU-Kerecis-Burn-US.pdf
KERECIS hf.
10x25 Solid Burn
In Commercial Distribution

  • 05694310960410 ()

  • Length: 10 Centimeter
  • Width: 25 Centimeter
50202S22D0D

  • Animal-derived wound matrix dressing
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
Integra Tissue Expander, 2.3 X 4.5cm, 3cm Projection, 14cc Fill, Pear Shape, Micro Remote Port Tubing
PMT CORPORATION
3611-684
In Commercial Distribution

  • 00650551004660 ()


  • Skin-port tissue expander
TISSUE EXPANDER, ANATOMICAL, ENHANCED TEXTURED SURFACE, INTERNAL RESEAL PORT, SUTURE TABS, 11.5X10CM, 250CC FILL VOLUME, 4.5CM PROJECTION
PMT CORPORATION
3616ES-14-ST
In Commercial Distribution

  • 00650551004585 ()


  • Skin-port tissue expander
TE IRREGULAR, SMOOTH, 9.3 X 13.2cm, PROJECTION 4.2cm, FILL 330cc
PMT CORPORATION
3611-683
In Commercial Distribution

  • 00650551004578 ()


  • Skin-port tissue expander
TE IRREGULAR, SMOOTH, 2-STAGE, 8.2 X 13.8cm, PROJECTION 6.4cm, FILL 550cc
PMT CORPORATION
3611-682-2
In Commercial Distribution

  • 00650551004561 ()


  • Skin-port tissue expander
TE IRREGULAR, SMOOTH, 4.5 X 6.1cm, PROJECTION 2.4cm, FILL 42cc
PMT CORPORATION
3611-681
In Commercial Distribution

  • 00650551004554 ()


  • Skin-port tissue expander
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