Integra® Dermal Regeneration Template

FDA UDI

Class U (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name: Integra® Dermal Regeneration Template FDA UDI
Generic Name: Animal-derived wound matrix dressing FDA UDI
Device Name: Integra® MATRIX WOUND DRESSING 4 in X 10 in (10 cm X 25 cm) FDA UDI
Model / Reference: 54101 FDA UDI
Description: Integra® MATRIX WOUND DRESSING 4 in X 10 in (10 cm X 25 cm) FDA UDI

Identifiers

Catalog Number: 54101 FDA UDI
Primary DI / UDI-DI: 10381780032304 FDA UDI
510(k) Number: K022127 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 — 4 Inch FDA UDI
Length — 10 Inch FDA UDI
Width — 10 Centimeter FDA UDI
Length — 25 Centimeter FDA UDI

Category: Animal-derived wound matrix dressing

Integra® Dermal Regeneration Template by Integra Lifesciences Corp. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Animal-derived wound matrix dressing.

PuraPly™ Antimicrobial XT Wound Matrix — ORGANOGENESIS INC. · Class I
DermaCol/Ag Healogics by DermaRite — DERMARITE INDUSTRIES LLC · U
Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery · U
Kerecis® GraftGuide® — KERECIS hf. · U
HealiAid Collagen Wound Dressing — MAXIGEN BIOTECH INC. · U
Solventum™ Promogran™ — Solventum US LLC · U
Simpurity — SAFE N SIMPLE LLC · U
ProgenaMatrix — Progenacare Global, LLC · U

Cleared under the same submission

K022127 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 48aa909e-d545-4944-8ebe-b0c5fcaebfd2 38 fields · synced May 30, 2026