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GORE ENFORM Preperitoneal Biomaterial

FDA UDI

Class II (US FDA UDI)

by W. L. Gore & Associates, Inc

Identity

Trade Name
GORE ENFORM Preperitoneal Biomaterial FDA UDI
Generic Name
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable FDA UDI
Device Name
ENFORM PREPERITONEAL 8cmX16cm Biomaterial FDA UDI
Model / Reference
GBWR0816 FDA UDI
Description
ENFORM PREPERITONEAL 8cmX16cm Biomaterial FDA UDI

Identifiers

Catalog Number
GBWR0816 FDA UDI
Primary DI / UDI-DI
00733132644582 FDA UDI
FDA Product Code
OXF FDA UDI
OWZ FDA UDI
OXC FDA UDI
OWT 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
Width — 16 Centimeter FDA UDI
Length — 8 Centimeter FDA UDI

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

GORE ENFORM Preperitoneal Biomaterial 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 fed3ff61-75d8-45aa-ab07-97a7c1cd1848 36 fields · synced May 31, 2026