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 | |
|---|---|---|---|
| 05694310966450 | Kerecis SurgiBind® Tendon Protect - Fish-skin for tendon repair. Kerecis SurgiBind® Tendon Protect is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. IFU: https://www.kerecis.com/ifus/ifu-surgibind-tendon-protect/ | 7032878752 | info@kerecis.com |
| 05694310966467 | Kerecis SurgiBind® Tendon Protect - Fish-skin for tendon repair. Kerecis SurgiBind® Tendon Protect is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. IFU: https://www.kerecis.com/ifus/ifu-surgibind-tendon-protect/ | 7032878752 | info@kerecis.com |
| 05694310968003 | Kerecis MariGen® - Fish-skin graft for wound management. Kerecis MariGen® is indicated for the management of wounds including: Partial-thickness wounds (extending through the epidermis or into dermis), Full-thickness wounds (extending through the dermis to deeper tissues such as subcutaneous fat, muscle, tendon or bone), 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/ | 7032878752 | info@kerecis.com |
| 05694310968027 | Kerecis MariGen® - Fish-skin graft for wound management. Kerecis MariGen® is indicated for the management of wounds including: Partial-thickness wounds (extending through the epidermis or into dermis), Full-thickness wounds (extending through the dermis to deeper tissues such as subcutaneous fat, muscle, tendon or bone), 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/ | 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 | 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
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Kerecis Limited
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