KERECIS hf.

Address:Eyrargata 2,Isafjordur Vestfiroir,IS

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- Catalog Number : 50202M13B0D

Device Description : Acellular fish skin for topical and surgical wounds.INTENDED USEKerecis® Burn is Acellular fish skin for topical and surgical wounds.INTENDED USEKerecis® Burn is indicated for the management of wounds including: - Partial and full-thickness wounds, - Trauma wounds (abrasions, lacerations, second-degree burns, skin tears).MeshedDouble Pouchedhttps://www.kerecis.com/wp-content/uploads/2020/10/A5-KM-19-0146-IFU-Kerecis-Burn-US.pdf

Device Class : U

Duns Number: 365732410

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 50202M14B0D

Device Description : Acellular fish skin for topical and surgical wounds.INTENDED USEKerecis® Burn is Acellular fish skin for topical and surgical wounds.INTENDED USEKerecis® Burn is indicated for the management of wounds including: - Partial and full-thickness wounds, - Trauma wounds (abrasions, lacerations, second-degree burns, skin tears).MeshedDouble Pouchedhttps://www.kerecis.com/wp-content/uploads/2020/10/A5-KM-19-0146-IFU-Kerecis-Burn-US.pdf

Device Class : U

Duns Number: 365732410

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 50200S00B0D

Device Description : Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for th Fish-skin graft for wound management. Kerecis Omega3 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-omega3-marigen/

Device Class : U

Duns Number: 365732410

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 50200S12B0D

Device Description : Acellular fish skin for topical and surgical wounds.INTENDED USE Kerecis® Omega 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 Wounds12 mm Circularhttps://www.kerecis.com/wp-content/uploads/2020/11/Instructions-for-Use-IFU.pdf

Device Class : U

Duns Number: 365732410

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 50200S14B0D

Device Description : Acellular fish skin for topical and surgical wounds.INTENDED USE Kerecis® Omega 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 Wounds14 mm Circularhttps://www.kerecis.com/wp-content/uploads/2020/11/Instructions-for-Use-IFU.pdf

Device Class : U

Duns Number: 365732410

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 50200S16B0D

Device Description : Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for th Fish-skin graft for wound management. Kerecis Omega3 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-omega3-marigen/

Device Class :

Duns Number: 365732410

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 50200F01B0D

Device Description : Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for th Fish-skin graft for wound management. Kerecis Omega3 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-omega3-marigen/

Device Class : U

Duns Number: 365732410

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 50200F02B0D

Device Description : Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for th Fish-skin graft for wound management. Kerecis Omega3 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-omega3-marigen/

Device Class : U

Duns Number: 365732410

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 50200F03B0D

Device Description : Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for th Fish-skin graft for wound management. Kerecis Omega3 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-omega3-marigen/

Device Class : U

Duns Number: 365732410

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 50200S04B0D

Device Description : Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for th Fish-skin graft for wound management. Kerecis Omega3 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-omega3-marigen/

Device Class :

Duns Number: 365732410

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1