Address:Eyrargata 2,Isafjordur Vestfiroir,IS
Device Description : Bilayer wound management medical device product made from fish skin and silicone Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Omega3 MariGen® Shield 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-omega3-marigen-shield/
Device Class : U
Duns Number: 365732410
Premarket Exempt : No
Prescription Use : Yes
Device Description : Bilayer wound management medical device product made from fish skin and silicone Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Omega3 MariGen® Shield 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-omega3-marigen-shield/
Device Class : U
Duns Number: 365732410
Premarket Exempt : No
Prescription Use : Yes
Device Description : Fish skin for surgical use. INTENDED USE Kerecis® Omega3 SurgiBind™ is indicated Fish skin for surgical use. INTENDED USE Kerecis® Omega3 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. https://www.kerecis.com/wp-content/uploads/2021/10/KM-21-0117v2-IFU-Kerecis-SurgiBind.pdf
Device Class : 2
Duns Number: 365732410
Premarket Exempt : No
Prescription Use : Yes
Device Description : Fsh skin for surgical use. INTENDED USE Kerecis® Omega3 SurgiBind™ is indicated Fsh skin for surgical use. INTENDED USE Kerecis® Omega3 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. https://www.kerecis.com/wp-content/uploads/2021/10/KM-21-0117v2-IFU-Kerecis-SurgiBind.pdf
Device Class : 2
Duns Number: 365732410
Premarket Exempt : No
Prescription Use : Yes
Device Description : Fish-Skin Graft for Surgical Use. Kerecis® Omega3 SurgiClose is indicated for th Fish-Skin Graft for Surgical Use. Kerecis® Omega3 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-omega3-surgiclose/
Device Class : U
Duns Number: 365732410
Premarket Exempt : No
Prescription Use : Yes
Device Description : Fish-Skin Graft for Surgical Use. Kerecis® Omega3 SurgiClose is indicated for th Fish-Skin Graft for Surgical Use. Kerecis® Omega3 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-omega3-surgiclose/
Device Class : U
Duns Number: 365732410
Premarket Exempt : No
Prescription Use : Yes
Device Description : Fish-Skin Graft for Surgical Use. Kerecis® Omega3 SurgiClose is indicated for th Fish-Skin Graft for Surgical Use. Kerecis® Omega3 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-omega3-surgiclose/
Device Class : U
Duns Number: 365732410
Premarket Exempt : No
Prescription Use : Yes
Device Description : Fish-Skin Graft for Surgical Use. Kerecis® Omega3 SurgiClose is indicated for th Fish-Skin Graft for Surgical Use. Kerecis® Omega3 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-omega3-surgiclose/
Device Class : U
Duns Number: 365732410
Premarket Exempt : No
Prescription Use : Yes
Device Description : Fish-Skin Graft for Surgical Use. Kerecis® Omega3 SurgiClose is indicated for th Fish-Skin Graft for Surgical Use. Kerecis® Omega3 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-omega3-surgiclose/
Device Class : U
Duns Number: 365732410
Premarket Exempt : No
Prescription Use : Yes
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
Prescription Use : Yes