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GORE BIO-A Tissue Reinforcement

FDA UDI

Class II (US FDA UDI)

by W. L. Gore & Associates, Inc

Identity

Trade Name
GORE BIO-A Tissue Reinforcement FDA UDI
Generic Name
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable FDA UDI
Device Name
BIO-A TISSUE REINFORCEMENT 20cmX20cm FDA UDI
Model / Reference
FS2020 FDA UDI
Description
BIO-A TISSUE REINFORCEMENT 20cmX20cm FDA UDI

Identifiers

Catalog Number
FS2020 FDA UDI
Primary DI / UDI-DI
00733132605446 FDA UDI
FDA Product Code
OWT FDA UDI
OWZ FDA UDI
OXC FDA UDI
OXF FDA UDI
GMDN Term
Extra-gynaecological surgical mesh, synthetic polymer, 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Length — 20 Centimeter FDA UDI
Width — 20 Centimeter FDA UDI

Category: Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GORE BIO-A Tissue Reinforcement by W. L. Gore & Associates, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
W. L. Gore & Associates, Inc

Sources (1)

  • FDA UDI 3af9bbb1-a790-428b-9365-a3be75c5e7f6 36 fields · synced Jun 8, 2026