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SurgiMend®

FDA UDI

Class II (US FDA UDI)

by Tei Biosciences Inc.

Identity

Trade Name
SurgiMend® FDA UDI
Generic Name
Extra-gynaecological surgical mesh, collagen, non-bioabsorbable FDA UDI
Device Name
SurgiMend® 16 cm x 20 cm FDA UDI
Model / Reference
606-001-008 FDA UDI
Description
SurgiMend® 16 cm x 20 cm FDA UDI

Identifiers

Catalog Number
606-001-008 FDA UDI
Primary DI / UDI-DI
10381780112662 FDA UDI
510(k) Number
K071807 FDA UDI
K083898 FDA UDI
FDA Product Code
FTM FDA UDI
GMDN Term
Extra-gynaecological surgical mesh, collagen, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3300 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

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Extra-gynaecological surgical mesh, collagen, non-bioabsorbable

SurgiMend® by Tei Biosciences Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Extra-gynaecological surgical mesh, collagen, non-bioabsorbable.

Cleared under the same submission

K071807 also covers:

K083898 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tei Biosciences Inc.

Sources (1)

  • FDA UDI eb50ef68-7469-4b3c-aaba-0ce94aa5d69d 38 fields · synced May 30, 2026