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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 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.
4x6 cm Meshed 2:1
In Commercial Distribution

  • 05694310963848 ()
  • 05694310963831 ()

  • Width: 6 Centimeter
  • Length: 8 Centimeter
50205N20D0D

  • Collagen wound matrix dressing
Fsh skin for surgical use. INTENDED USE Kerecis® SurgiBind™ is indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgibind/
KERECIS hf.
3x20 cm Fenestrated
In Commercial Distribution

  • 05694310963824 ()
  • 05694310963817 ()

  • Width: 3 Centimeter
  • Length: 20 Centimeter
50241G19D0D

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Fish skin for surgical use. INTENDED USE Kerecis® SurgiBind™ is indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgibind/
KERECIS hf.
3x20 cm
In Commercial Distribution

  • 05694310963800 ()
  • 05694310963794 ()

  • Width: 3 Centimeter
  • Length: 20 Centimeter
50241S19D0D

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
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.
30 mm Circular
In Commercial Distribution

  • 05694310963787 ()
  • 05694310963770 ()

  • Outer Diameter: 30 Millimeter
50215I52B0D

  • 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.
20 mm Circular
In Commercial Distribution

  • 05694310963763 ()
  • 05694310963756 ()

  • Outer Diameter: 20 Millimeter
50215H51B0D

  • 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.
7x10 cm
In Commercial Distribution

  • 05694310962445 ()
  • 05694310962438 ()

  • Length: 7 Centimeter
  • Width: 10 Centimeter
50200S03B0D

  • 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.
3x7 cm
In Commercial Distribution

  • 05694310962414 ()
  • 05694310962421 ()

  • Length: 3 Centimeter
  • Width: 7 Centimeter
50200S02B0D

  • 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.
3x3.5 cm
In Commercial Distribution

  • 05694310962391 ()
  • 05694310962407 ()

  • Length: 3 Centimeter
  • Width: 3.5 Centimeter
50200S01B0D

  • 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 8x10 cm
In Commercial Distribution

  • 05694310962247 ()
  • 05694310962230 ()
  • 05694310962261 ()

  • Length: 8 Centimeter
  • Width: 10 Centimeter
50200N13B0D

  • 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 7x8 cm
In Commercial Distribution

  • 05694310962223 ()
  • 05694310962216 ()
  • 05694310962254 ()

  • Length: 7 Centimeter
  • Width: 8 Centimeter
50200N11B0D

  • Collagen wound matrix dressing
Fish skin for surgical use. INTENDED USE Kerecis® SurgiBind™ is indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgibind/
KERECIS hf.
300 sq cm Fenestrated
In Commercial Distribution

  • 05694310961981 ()
  • 05694310961974 ()

  • Area/Surface Area: 300 Square centimeter
50241G23D0D

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Fish skin for surgical use. INTENDED USE Kerecis® SurgiBind™ is indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgibind/
KERECIS hf.
250 sq cm Fenestrated
In Commercial Distribution

  • 05694310961967 ()
  • 05694310961950 ()

  • Area/Surface Area: 250 Square centimeter
50241G24D0D

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Fish skin for surgical use. INTENDED USE Kerecis® SurgiBind™ is indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgibind/
KERECIS hf.
3x12 cm Fenestrated
In Commercial Distribution

  • 05694310961943 ()
  • 05694310961936 ()

  • Length: 3 Centimeter
  • Width: 12 Centimeter
50241G10D0D

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Fish skin for surgical use. INTENDED USE Kerecis® SurgiBind™ is indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgibind/
KERECIS hf.
3x7 cm Fenestrated
In Commercial Distribution

  • 05694310961929 ()
  • 05694310961912 ()

  • Length: 3 Centimeter
  • Width: 7 Centimeter
50241G02D0D

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Fish skin for surgical use. INTENDED USE Kerecis® SurgiBind™ is indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgibind/
KERECIS hf.
300 sq cm
In Commercial Distribution

  • 05694310961905 ()
  • 05694310961899 ()

  • Area/Surface Area: 300 Square centimeter
50241S23D0D

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Fish skin for surgical use. INTENDED USE Kerecis® SurgiBind™ is indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgibind/
KERECIS hf.
250 sq cm
In Commercial Distribution

  • 05694310961882 ()
  • 05694310961875 ()

  • Area/Surface Area: 250 Square centimeter
50241S24D0D

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Fish skin for surgical use. INTENDED USE Kerecis® SurgiBind™ is indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgibind/
KERECIS hf.
3x12 cm
In Commercial Distribution

  • 05694310961868 ()
  • 05694310961851 ()

  • Length: 3 Centimeter
  • Width: 12 Centimeter
50241S10D0D

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Fish skin for surgical use. INTENDED USE Kerecis® SurgiBind™ is indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgibind/
KERECIS hf.
3x7 cm
In Commercial Distribution

  • 05694310961844 ()
  • 05694310961837 ()

  • Length: 3 Centimeter
  • Width: 7 Centimeter
50241S02D0D

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Fish skin for surgical use. INTENDED USE Kerecis® SurgiBind™ is indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgibind/
KERECIS hf.
7x20 cm Fenestrated
In Commercial Distribution

  • 05694310961820 ()
  • 05694310961813 ()

  • Length: 7 Centimeter
  • Width: 20 Centimeter
50241G21D0D

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Fsh skin for surgical use. INTENDED USE Kerecis® SurgiBind™ is indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgibind/
KERECIS hf.
7x10 cm Fenestrated
In Commercial Distribution

  • 05694310961806 ()
  • 05694310961790 ()

  • Length: 7 Centimeter
  • Width: 10 Centimeter
50241G03D0D

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Fish skin for surgical use. INTENDED USE Kerecis® SurgiBind™ is indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgibind/
KERECIS hf.
4x7 cm Fenestrated
In Commercial Distribution

  • 05694310961783 ()
  • 05694310961776 ()

  • Length: 4 Centimeter
  • Width: 7 Centimeter
50241G09D0D

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Fish skin for surgical use. INTENDED USE Kerecis® SurgiBind™ is indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgibind/
KERECIS hf.
7x20 cm
In Commercial Distribution

  • 05694310961769 ()
  • 05694310961752 ()

  • Length: 7 Centimeter
  • Width: 20 Centimeter
50241S21D0D

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Fish skin for surgical use. INTENDED USE Kerecis® SurgiBind™ is indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgibind/
KERECIS hf.
7x10 cm
In Commercial Distribution

  • 05694310961745 ()
  • 05694310961738 ()

  • Length: 7 Centimeter
  • Width: 10 Centimeter
50241S03D0D

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Fish skin for surgical use. INTENDED USE Kerecis® SurgiBind™ is indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. IFU: https://www.kerecis.com/ifus/ifu-kerecis-surgibind/
KERECIS hf.
4x7 cm
In Commercial Distribution

  • 05694310961721 ()
  • 05694310961714 ()

  • Length: 4 Centimeter
  • Width: 7 Centimeter
50241S09D0D

  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
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.
Micro 38 sq cm
In Commercial Distribution

  • 05694310961660 ()
  • 05694310961653 ()

  • Area/Surface Area: 38 Square centimeter
50200P04D0D

  • 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.
Micro 19 sq cm
In Commercial Distribution

  • 05694310961622 ()
  • 05694310961615 ()

  • Area/Surface Area: 19 Square centimeter
50200P02D0D

  • 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.
Micro 8 sq cm
In Commercial Distribution

  • 05694310961608 ()
  • 05694310961592 ()

  • Area/Surface Area: 8 Square centimeter
50200P01B0D

  • 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.
Micro 4 sq cm
In Commercial Distribution

  • 05694310961578 ()
  • 05694310961585 ()

  • Area/Surface Area: 4 Square centimeter
50200P00B0D

  • Collagen 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.
Micro 38 sq cm
In Commercial Distribution

  • 05694310961554 ()
  • 05694310961561 ()

  • Area/Surface Area: 38 Square centimeter
50205P04D0D

  • Collagen 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.
Micro 19 sq cm
In Commercial Distribution

  • 05694310961547 ()
  • 05694310961530 ()

  • Area/Surface Area: 19 Square centimeter
50205P02D0D

  • Collagen wound matrix dressing
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