Integra® DuraFlex®

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name: Integra® DuraFlex® FDA UDI
Generic Name: Dura mater graft, bovine FDA UDI
Device Name: Integra® DuraFlex™ Suturable Dural Graft 12 cm x 16 cm FDA UDI
Model / Reference: BP11216 FDA UDI
Description: Integra® DuraFlex™ Suturable Dural Graft 12 cm x 16 cm FDA UDI

Identifiers

Catalog Number: BP11216 FDA UDI
Primary DI / UDI-DI: 10381780511373 FDA UDI
510(k) Number: K132850 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 12 Centimeter FDA UDI
Width — 16 Centimeter FDA UDI

Category: Dura mater graft, bovine

Integra® DuraFlex® 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

K132850 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

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Manufacturer

Manufacturer: Integra Lifesciences Corp.

Sources (1)

FDA UDI ebf244f7-3d06-4400-abf6-aee10a3d74af 38 fields · synced Jun 1, 2026