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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 hf.
Expanse 4x4 cm
In Commercial Distribution

  • 05694310964517 ()
  • 05694310964500 ()

  • Width: 4 Centimeter
  • Length: 3 Centimeter
50200N44B0D

  • 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. IFU: https://www.kerecis.com/ifus/ifu-kerecis-marigen/
KERECIS hf.
Expanse 3x3 cm
In Commercial Distribution

  • 05694310964494 ()
  • 05694310964487 ()

  • Length: 3 Centimeter
  • Width: 3 Centimeter
50200N43B0D

  • 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. IFU: https://www.kerecis.com/ifus/ifu-kerecis-marigen/
KERECIS hf.
Expanse 2x2 cm
In Commercial Distribution

  • 05694310964470 ()
  • 05694310964463 ()

  • Length: 2 Centimeter
  • Width: 2 Centimeter
50200N42B0D

  • Collagen wound matrix dressing
Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Spiral 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.
Diameter: 30mm
In Commercial Distribution

  • 05694310964371 ()
  • 05694310964364 ()

  • Outer Diameter: 30 Millimeter
50215K52B0D

  • Collagen wound matrix dressing
Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Standard 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.
Diameter: 50mm
In Commercial Distribution

  • 05694310964326 ()
  • 05694310964319 ()

  • Outer Diameter: 50 Millimeter
50215I53B0D

  • Collagen wound matrix dressing
Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide™ Mano 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-omega3-graftguide/
KERECIS hf.
Size L, 196 sq cm Dorsum Right / Palmar Left Meshed 2:1
In Commercial Distribution

  • 05694310964029 ()
  • 05694310964012 ()

  • Area/Surface Area: 196 Square centimeter
50202N36D0D

  • Collagen wound matrix dressing
Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide™ Mano 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-omega3-graftguide/
KERECIS hf.
Size L, 196 sq cm Dorsum Left / Palmar Right Meshed 2:1
In Commercial Distribution

  • 05694310964005 ()
  • 05694310963992 ()

  • Area/Surface Area: 196 Square centimeter
50202N35D0D

  • Collagen wound matrix dressing
Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide™ Mano 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-omega3-graftguide/
KERECIS hf.
Size M, 147 sq cm Dorsum Right / Palmar Left Meshed 2:1
In Commercial Distribution

  • 05694310963985 ()
  • 05694310963978 ()

  • Area/Surface Area: 147 Square centimeter
50202N34D0D

  • Collagen wound matrix dressing
Fish-Skin Graft for Burn Wound Management. Kerecis® GraftGuide™ Mano 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-omega3-graftguide/
KERECIS hf.
Size M, 147 sq cm Dorsum Left / Palmar Right Meshed 2:1
In Commercial Distribution

  • 05694310963954 ()
  • 05694310963961 ()

  • Area/Surface Area: 147 Square centimeter
50202N33D0D

  • Collagen wound matrix dressing
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.
Micro 114 sq cm
In Commercial Distribution

  • 05694310963947 ()
  • 05694310963930 ()

  • Area/Surface Area: 114 Square centimeter
50202P32D0D

  • Collagen wound matrix dressing
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