Durepair™

FDA UDI

Class II (US FDA UDI)

by Tei Biosciences Inc.

Identity

Trade Name: Durepair™ FDA UDI
Generic Name: Dura mater graft, bovine FDA UDI
Device Name: Durepair™ 5.0cm x 5.0cm (2" x 2") FDA UDI
Model / Reference: 62100 FDA UDI
Description: Durepair™ 5.0cm x 5.0cm (2" x 2") FDA UDI

Identifiers

Catalog Number: 62100 FDA UDI
Primary DI / UDI-DI: 10381780540854 FDA UDI
510(k) Number: K161370 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

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Length — 5 Centimeter FDA UDI
Length — 2 Inch FDA UDI
Width — 2 Inch FDA UDI
Width — 5 Centimeter FDA UDI

Category: Dura mater graft, bovine

Durepair™ by Tei Biosciences Inc. — 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
Integra® DuraFlex® — Integra Lifesciences Corp. · Class II
DuraMatrix-Onlay Conform — COLLAGEN MATRIX, INC. · Class II
DurAdapt — COLLAGEN MATRIX, INC. · Class II
DuraGen® Plus — Integra Lifesciences Corp. · Class II
DuraGen XS™ Dural Regeneration Matrix — Integra Lifesciences Corp. · Class II
DuraGen® — Integra Lifesciences Corp. · Class II

Cleared under the same submission

K161370 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: Tei Biosciences Inc.

Sources (1)

FDA UDI 199d21d1-666d-4331-9d5f-9d1d658ade3e 38 fields · synced May 30, 2026