DuraGen® Plus

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name: DuraGen® Plus FDA UDI
Generic Name: Dura mater graft, bovine FDA UDI
Device Name: DuraGen® Plus Dural Regeneration Matrix, 3 in x 3 in (7.5 cm x 7.5 cm) FDA UDI
Model / Reference: DP5033 FDA UDI
Description: DuraGen® Plus Dural Regeneration Matrix, 3 in x 3 in (7.5 cm x 7.5 cm) FDA UDI

Identifiers

Catalog Number: DP-5033 FDA UDI
Primary DI / UDI-DI: 10381780070948 FDA UDI
510(k) Number: K032693 FDA UDI
FDA Product Code: GXQ FDA UDI
GMDN Term: Dura mater graft, bovine FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5910 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Category: Dura mater graft, bovine

DuraGen® Plus by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dura mater graft, bovine.

DurAdapt — COLLAGEN MATRIX, INC. · Class II
DurAdapt — COLLAGEN MATRIX, INC. · Class II
DuraMatrix-Onlay Conform — COLLAGEN MATRIX, INC. · Class II
Durepair™ — TEI BIOSCIENCES INC. · Class II
DurAdapt — COLLAGEN MATRIX, INC. · Class II
Durepair™ — TEI BIOSCIENCES INC. · Class II
DurAdapt — COLLAGEN MATRIX, INC. · Class II
DURA-GUARD Dural Repair Patch — SYNOVIS LIFE TECHNOLOGIES, INC. · Class II

Cleared under the same submission

K032693 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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Integra Lifesciences Corp.

Sources (1)

FDA UDI 1da1f887-fca2-4bfb-8b83-8501b5828bef 38 fields · synced May 30, 2026