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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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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.
7x10 cm
In Commercial Distribution

  • 05694310960380 ()
  • 05694310960373 ()

  • Length: 7 Centimeter
  • Width: 10 Centimeter
50202S03D0D

  • 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.
7x20 cm
Not in Commercial Distribution

  • 05694310960311 ()
  • 05694310960588 ()

  • Width: 7 Centimeter
  • Length: 20 Centimeter
50200S21B0D

  • 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 Meshed https://www.kerecis.com/wp-content/uploads/2020/11/Instructions-for-Use-IFU.pdf
KERECIS hf.
7x7 Meshed Wound
Not in Commercial Distribution

  • 05694310960281 ()
  • 05694310960274 ()

  • Width: 7 Centimeter
  • Length: 7 Centimeter
50200M04B0D

  • 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.
7x7 cm
In Commercial Distribution

  • 05694310960236 ()
  • 05694310960243 ()

  • Length: 7 Centimeter
  • Width: 7 Centimeter
50200S04B0D

  • 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.
7x10 cm Fenestrated
In Commercial Distribution

  • 05694310960229 ()
  • 05694310960212 ()

  • Width: 7 Centimeter
  • Length: 10 Centimeter
50200F03B0D

  • 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.
3x3.5 cm Fenestrated
In Commercial Distribution

  • 05694310960182 ()
  • 05694310960175 ()

  • Width: 3 Centimeter
  • Length: 3.5 Centimeter
50200F01B0D

  • 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.
16 mm Circular
In Commercial Distribution

  • 05694310960151 ()
  • 05694310960168 ()

  • Circumference: 16 Millimeter
50200S16B0D

  • 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 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
No Description
Coloplast A/S
RMA212
In Commercial Distribution

  • 05701780272155 ()
  • 05701780272148 ()
  • 05701780272162 ()

  • Catheter Gauge: 12 French
RMA212

  • Urological surgical procedure kit, non-medicated, single-use
No Description
Coloplast A/S
RMA210
In Commercial Distribution

  • 05701780272131 ()
  • 05701780272124 ()
  • 05701780272117 ()

  • Catheter Gauge: 10 French
RMA210

  • Urological surgical procedure kit, non-medicated, single-use
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