Kerecis Arlington

Matched from indexed company URL: Kerecis Limited

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30132811273013281127Kerecis Arlington1Y2026-01-012101 Wilson Blvd Suite 900 Arlington VA US 22201
30164292463016429246KERECIS EHF1N2026-01-01Sundstraeti 38 Isafjordur Vestfiroir IS 400
30319765823031976582Kerecis Minneapolis1Y2026-01-011601 West River Road N Suite B117 Minneapolis MN US 55411

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
05694310966450Kerecis 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/7032878752info@kerecis.com
05694310966467Kerecis 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/7032878752info@kerecis.com
05694310968003Kerecis 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/7032878752info@kerecis.com
05694310968027Kerecis 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/7032878752info@kerecis.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2924891255655608K243843Tendon Protect (50242)OWY2025-06-04
2924891671447998K213231Kerecis SiliconeKGN2022-06-29
2924891424342713K202430Kerecis ReconstructOXH2021-05-02
2342691749320705K190528MariGen Wound ExtraKGN2019-07-10
2924891749320705K190528MariGen Wound ExtraKGN2019-07-10
2342691926044438K132343MARIGEN WOUND DRESSINGKGN2013-10-23
2924891926044438K132343MARIGEN WOUND DRESSINGKGN2013-10-23

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
KGN52022-06-29
OWY12025-06-04
OXH12021-05-02

PMN

GUDID

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/

KERECIS hf.

2026-01-30

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/

KERECIS hf.

2026-01-30

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/

KERECIS hf.

2026-01-30

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/

KERECIS hf.

2026-01-30

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/

KERECIS hf.

2026-01-30

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/

KERECIS hf.

2026-01-30

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/

KERECIS hf.

2025-08-29

Kerecis® SurgiClose® Silicone - Bilayer wound management medical device product made from fish skin and silicone. Kerecis® SurgiClose® 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-surgiclose-silicone/

KERECIS hf.

2025-08-20

Kerecis® SurgiClose® Silicone - Bilayer wound management medical device product made from fish skin and silicone. Kerecis® SurgiClose® 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-surgiclose-silicone/

KERECIS hf.

2025-08-20

Kerecis® SurgiClose® Silicone - Bilayer wound management medical device product made from fish skin and silicone. Kerecis® SurgiClose® 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-surgiclose-silicone/

KERECIS hf.

2025-08-20

Kerecis® SurgiClose® Silicone - Bilayer wound management medical device product made from fish skin and silicone. Kerecis® SurgiClose® 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-surgiclose-silicone/

KERECIS hf.

2025-08-20

Kerecis® Shield® Spiral - Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield® Spiral 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-shield/

KERECIS hf.

2024-12-27

Kerecis® SurgiClose® Silicone - Bilayer wound management medical device product made from fish skin and silicone. Kerecis® SurgiClose® 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-surgiclose-silicone/

KERECIS hf.

2024-12-27

Kerecis® SurgiClose® Silicone - Bilayer wound management medical device product made from fish skin and silicone. Kerecis® SurgiClose® 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-surgiclose-silicone/

KERECIS hf.

2024-12-27

Kerecis® Shield® Adhesive - Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield® Adhesive 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-shield/

KERECIS hf.

2024-12-20

Kerecis® MariGen™ - Fish-skin graft for wound management. Kerecis® 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-marigen/

KERECIS hf.

2024-09-03

Kerecis® MariGen™ - Fish-skin graft for wound management. Kerecis® 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-marigen/

KERECIS hf.

2024-09-02

Kerecis® Shield™ Spiral - Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Spiral 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-shield/

KERECIS hf.

2024-06-13

Kerecis® Shield™ Standard - Bilayer wound management medical device product made from fish skin and silicone. Kerecis® Shield™ Standard 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-shield/

KERECIS hf.

2024-01-16

Kerecis® Omega3 SurgiClose - 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/

KERECIS hf.

2022-09-08

Kerecis® Omega3 SurgiClose - 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/

KERECIS hf.

2022-09-08

Kerecis® Omega3 SurgiClose - 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/

KERECIS hf.

2022-09-08

Kerecis® Omega3 SurgiClose - 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/

KERECIS hf.

2022-09-08

Kerecis® Omega3 SurgiClose - 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/

KERECIS hf.

2022-09-08

Kerecis® Omega3 MariGen® Shield - 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/

KERECIS hf.

2022-08-22

Kerecis® Omega3 MariGen® Shield - 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/

KERECIS hf.

2022-08-22

Kerecis® Omega3 MariGen - 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/

KERECIS hf.

2022-02-17

Kerecis® Omega3 MariGen - 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/

KERECIS hf.

2022-02-17

Kerecis® Omega3 MariGen - 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

KERECIS hf.

2022-02-17

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