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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 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

  • Collagen 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

  • Collagen 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

  • Collagen 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

  • Collagen 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

  • Collagen 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

  • Collagen 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

  • Collagen 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

  • Collagen 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). Pentagon Meshed Double Pouched https://www.kerecis.com/wp-content/uploads/2020/10/A5-KM-19-0146-IFU-Kerecis-Burn-US.pdf
KERECIS hf.
250cm2 Meshed Burn
In Commercial Distribution

  • 05694310960670 ()
  • 05694310960687 ()

  • Length: 250 Centimeter
  • Width: 250 Centimeter
50202M24D0D

  • Collagen wound matrix dressing
No Description
BIOMET SPINE LLC
14-524038E
In Commercial Distribution

  • 00880304983816 ()

  • HF Plug
14-524038E

  • Bone-screw internal spinal fixation system, sterile
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