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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® 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 14 mm Circular https://www.kerecis.com/wp-content/uploads/2020/11/Instructions-for-Use-IFU.pdf
KERECIS hf.
14 mm Solid Circular Wound
Not in Commercial Distribution

  • 05694310960144 ()
  • 05694310960137 ()

  • Circumference: 14 Millimeter
50200S14B0D

  • Animal-derived wound matrix dressing
Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® 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/ifus/ifu-kerecis-omega3-marigen/
KERECIS hf.
12 mm Solid Circular Wound
Not in Commercial Distribution

  • 05694310960120 ()
  • 05694310960113 ()

  • Circumference: 12 Millimeter
50200S12B0D

  • 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. https://www.kerecis.com/ifus/ifu-kerecis-marigen/
KERECIS hf.
1.75x1.75 cm
In Commercial Distribution

  • 05694310960069 ()
  • 05694310960052 ()

  • Width: 1.75 Centimeter
  • Length: 1.75 Centimeter
50200S00B0D

  • 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.
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
TISSUE EXPANDER, RECTANGLE, SMOOTH, 2-STAGE, INTERNAL PORT, SUTURE TABS
PMT CORPORATION
3611-233-2I-ST
In Commercial Distribution

  • 00650551101987 ()

  • Projection 12 Centimeter
  • Total Volume: 1600 Centiliter
  • Length: 17 Centimeter
  • Width: 12 Centimeter
3611-233-2I-ST

  • Skin-port tissue expander
TISSUE EXPANDER, IRREGULAR CURVE, SMOOTH, 2-STAGE
PMT CORPORATION
3614-535-2
In Commercial Distribution

  • 00650551101963 ()

  • Projection 7.5 Centimeter
  • Total Volume: 1100 Centiliter
  • Length: 17 Centimeter
  • Width: 12 Centimeter
3614-535-2

  • Skin-port tissue expander
TISSUE EXPANDER, IRREGULAR CURVE, SMOOTH, 2-STAGE, MICRO REMOTE TUBING, REINFORCED BACKING
PMT CORPORATION
3614-534-2
In Commercial Distribution

  • 00650551101956 ()

  • Projection 7 Centimeter
  • Total Volume: 300 Centiliter
  • Length: 9 Centimeter
  • Width: 7.4 Centimeter
3614-534-2

  • Skin-port tissue expander
TISSUE EXPANDER, RECTANGLE, SMOOTH
PMT CORPORATION
3610-592
In Commercial Distribution

  • 00650551101918 ()

  • Projection 2.5 Centimeter
  • Total Volume: 8 Centiliter
  • Length: 3 Centimeter
  • Width: 2 Centimeter
3610-592

  • Skin-port tissue expander
TISSUE EXPANDER, RECTANGLE, SMOOTH, 2-STAGE, INTERNAL PORT
PMT CORPORATION
3610-587-2I
In Commercial Distribution

  • 00650551101857 ()

  • Projection 8 Centimeter
  • Total Volume: 2000 Centiliter
  • Length: 15 Centimeter
  • Width: 20 Centimeter
3610-587-2I

  • Skin-port tissue expander
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