Tendon Protect (50242)
Kerecis Limited
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013281127 | 3013281127 | Kerecis Arlington | 1 | Y | 2026-01-01 | 2101 Wilson Blvd Suite 900 Arlington VA US 22201 |
| 3016429246 | 3016429246 | KERECIS EHF | 1 | N | 2026-01-01 | Sundstraeti 38 Isafjordur Vestfiroir IS 400 |
| 3031976582 | 3031976582 | Kerecis Minneapolis | 1 | Y | 2026-01-01 | 1601 West River Road N Suite B117 Minneapolis MN US 55411 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 05694310969468 | MariGen® Compact - Wound management medical device product made from fish skin. Kerecis MariGen® Compact 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-marigen-compact | 7032878752 | info@kerecis.com |
| 05694310969482 | MariGen® Compact - Wound management medical device product made from fish skin. Kerecis MariGen® Compact 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-marigen-compact | 7032878752 | info@kerecis.com |
| 05694310969505 | MariGen® Compact - Wound management medical device product made from fish skin. Kerecis MariGen® Compact 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-marigen-compact | 7032878752 | info@kerecis.com |
| 05694310969529 | MariGen® Compact - Wound management medical device product made from fish skin. Kerecis MariGen® Compact 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-marigen-compact | 7032878752 | info@kerecis.com |
| 05694310969543 | SurgiClose® Compact - Wound management medical device product made from fish skin. Kerecis SurgiClose® Compact is indicated for the management of surgical 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-surgiclose-compact | 7032878752 | info@kerecis.com |
| 05694310969567 | SurgiClose® Compact - Wound management medical device product made from fish skin. Kerecis SurgiClose® Compact is indicated for the management of surgical 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-surgiclose-compact | 7032878752 | info@kerecis.com |
| 05694310969581 | SurgiClose® Compact - Wound management medical device product made from fish skin. Kerecis SurgiClose® Compact is indicated for the management of surgical 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-surgiclose-compact | 7032878752 | info@kerecis.com |
| 05694310969604 | SurgiClose® Compact - Wound management medical device product made from fish skin. Kerecis SurgiClose® Compact is indicated for the management of surgical 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-surgiclose-compact | 7032878752 | info@kerecis.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 292489 | 1255655608 | K243843 | Tendon Protect (50242) | OWY | 2025-06-04 |
| 292489 | 1580721905 | K241080 | Kerecis Parvus (50207) | KGN | 2024-08-21 |
| 292489 | 1671447998 | K213231 | Kerecis Silicone | KGN | 2022-06-29 |
| 292489 | 1424342713 | K202430 | Kerecis Reconstruct | OXH | 2021-05-02 |
| 234269 | 1749320705 | K190528 | MariGen Wound Extra | KGN | 2019-07-10 |
| 292489 | 1749320705 | K190528 | MariGen Wound Extra | KGN | 2019-07-10 |
| 234269 | 1926044438 | K132343 | MARIGEN WOUND DRESSING | KGN | 2013-10-23 |
| 292489 | 1926044438 | K132343 | MARIGEN WOUND DRESSING | KGN | 2013-10-23 |
Kerecis Limited
Kerecis Limited
Kerecis
Kerecis Limited
Kerecis Limited
Kerecis Limited
Kerecis Limited
Kerecis Limited
KERECIS LIMITED
2026-09-18
2026-09-18
2026-09-18
2026-09-18
2026-09-18
2026-09-18
2026-09-18
2026-09-18
2026-04-22
2026-04-22
2026-02-03
2026-02-03
2026-02-03
2026-02-03
2026-01-30
2026-01-30
2026-01-30
2026-01-30
2026-01-30
2026-01-30
2026-01-30
2026-01-30
2026-01-30
2026-01-30
2026-01-30
2026-01-30
2025-08-29
2025-08-29
2025-08-29
2025-08-29
2025-08-20
2025-08-20
2025-08-20
2025-08-20
2025-08-20
2025-08-20
2025-08-20
2025-08-20
2021-01-05
2021-01-05