INTEGRA Wound Matrix (Thin)

FDA UDI

Class U (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name: INTEGRA Wound Matrix (Thin) FDA UDI
Generic Name: Animal-derived wound matrix dressing FDA UDI
Device Name: Integra Wound Matrix and Integra Wound Matrix (Thin) are collagen-glycosaminoglycan wound dressings that maintain and support a healing environment for wound management. Integra Wound Matrix (Thin) has 50% less collagen compared to each of the corresponding sq cm sizes of Integra Wound Matrix. FDA UDI
Model / Reference: 52021T FDA UDI
Description: Integra Wound Matrix and Integra Wound Matrix (Thin) are collagen-glycosaminoglycan wound dressings that maintain and support a healing environment for wound management. Integra Wound Matrix (Thin) has 50% less collagen compared to each of the corresponding sq cm sizes of Integra Wound Matrix. FDA UDI

Identifiers

Catalog Number: 52021T FDA UDI
Primary DI / UDI-DI: 10381780032403 FDA UDI
510(k) Number: K113104 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: Width — 5 Centimeter FDA UDI
Length — 2 Inch FDA UDI
Length — 5 Centimeter FDA UDI
Width — 2 Inch FDA UDI

Category: Animal-derived wound matrix dressing

INTEGRA Wound Matrix (Thin) by Integra Lifesciences Corp. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Animal-derived wound matrix dressing.

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Cleared under the same submission

K113104 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: Integra Lifesciences Corp.

Sources (1)

FDA UDI bb235a22-d304-4d92-9a7c-7f542da96eb3 38 fields · synced May 30, 2026