Kerecis® MariGen®

FDA UDI

Class U (US FDA UDI)

by KERECIS hf.

Identity

Trade Name: Kerecis® MariGen® FDA UDI
Generic Name: Animal-derived wound matrix dressing FDA UDI
Device Name: 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/ FDA UDI
Model / Reference: Expanse cm 6 x 6 / Meshed 3:1 FDA UDI
Description: 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/ FDA UDI

Identifiers

Catalog Number: 50200O46B0D FDA UDI
Primary DI / UDI-DI: 05694310965347 FDA UDI
510(k) Number: K132343 FDA UDI
FDA Product Code: KGN FDA UDI
GMDN Term: Animal-derived wound matrix dressing FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 6 Centimeter FDA UDI
Width — 6 Centimeter FDA UDI

Category: Animal-derived wound matrix dressing

Kerecis® MariGen® by KERECIS hf. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K132343 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class U	Pending data

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Manufacturer

Manufacturer: KERECIS hf.

Sources (1)

FDA UDI ea5bcbb0-67a8-45fd-9ed0-1aae2456b3c0 38 fields · synced May 30, 2026