KERECIS hf.

Address:Eyrargata 2,Isafjordur Vestfiroir,IS

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- Catalog Number : 50200M04B0D

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 Woundshttps://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 : 50200M04B0D

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 WoundsMeshedhttps://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 : 50200M03B0D

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 WoundsMeshedhttps://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 : 50200S21B0D

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 : 50200S21D0D

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 WoundsDouble Pouchhttps://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 : 50202S21D0D

Device Description : Kerecis® Omega3 GraftGuide™Fish-Skin Graft for Burn Wound Management. Kerecis® O Kerecis® Omega3 GraftGuide™Fish-Skin Graft for Burn Wound Management. Kerecis® Omega3 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-omega3-graftguide/

Device Class : U

Duns Number: 365732410

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 50202S03D0D

Device Description : Fish-Skin Graft for Burn Wound Management. Kerecis® Omega3 GraftGuide™ is indica Fish-Skin Graft for Burn Wound Management. Kerecis® Omega3 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-omega3-graftguide/

Device Class : U

Duns Number: 365732410

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 50202S04D0D

Device Description : Fish-Skin Graft for Burn Wound Management. Kerecis® Omega3 GraftGuide™ is indica Fish-Skin Graft for Burn Wound Management. Kerecis® Omega3 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-omega3-graftguide/

Device Class : U

Duns Number: 365732410

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 50202S22D0D

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).Double 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 : 50202M22D0D

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