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TheraGenesis Meshed Bilayer Wound Matrix

FDA UDI

Class U (US FDA UDI)

by Gunze Limited

Identity

Trade Name
TheraGenesis Meshed Bilayer Wound Matrix FDA UDI
Generic Name
Animal-derived wound matrix dressing FDA UDI
Device Name
TheraGenesis Meshed Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine collagen sponge layer and a silicone film layer, and has slits to aid in the drainage of exudate. The collagen sponge layer should be applied to the wound surface. The device also contain a synthetic gauze material to add strength to the silicone film layer. When applied to full-thickness skin defects, TheraGenesis Meshed Bilayer Wound Matrix provides a scaffold for cellular invasion and capillary growth. TheraGenesis Meshed Bilayer Wound Matrix is offered in sheet form of various sizes and is provided terminally sterilized by ethylene oxide, is for single patient use, and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling. FDA UDI
Model / Reference
TG-M8260 FDA UDI
Description
TheraGenesis Meshed Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine collagen sponge layer and a silicone film layer, and has slits to aid in the drainage of exudate. The collagen sponge layer should be applied to the wound surface. The device also contain a synthetic gauze material to add strength to the silicone film layer. When applied to full-thickness skin defects, TheraGenesis Meshed Bilayer Wound Matrix provides a scaffold for cellular invasion and capillary growth. TheraGenesis Meshed Bilayer Wound Matrix is offered in sheet form of various sizes and is provided terminally sterilized by ethylene oxide, is for single patient use, and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling. FDA UDI

Identifiers

Catalog Number
TG-M8260 FDA UDI
Primary DI / UDI-DI
04967162947214 FDA UDI
510(k) Number
K191992 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Width — 82 Millimeter FDA UDI
Length — 60 Millimeter FDA UDI

Category: Animal-derived wound matrix dressing

TheraGenesis Meshed Bilayer Wound Matrix by Gunze Limited — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Animal-derived wound matrix dressing.

Cleared under the same submission

K191992 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gunze Limited

Sources (1)

  • FDA UDI 2af1bd08-45a3-4cac-affd-d41df7c1bd79 37 fields · synced May 30, 2026