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GORE SYNECOR Biomaterial

FDA UDI

Class II (US FDA UDI)

by W. L. Gore & Associates, Inc

Identity

Trade Name
GORE SYNECOR Biomaterial FDA UDI
Generic Name
Extra-gynaecological surgical mesh, composite-polymer FDA UDI
Device Name
GORE SYNECOR INTRAPERITONEAL 12cm Circular Biomaterial FDA UDI
Model / Reference
GKFC12 FDA UDI
Description
GORE SYNECOR INTRAPERITONEAL 12cm Circular Biomaterial FDA UDI

Identifiers

Catalog Number
GKFC12 FDA UDI
Primary DI / UDI-DI
00733132635344 FDA UDI
510(k) Number
K152609 FDA UDI
FDA Product Code
FTL FDA UDI
GMDN Term
Extra-gynaecological surgical mesh, composite-polymer 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
Outer Diameter — 12 Centimeter FDA UDI

Category: Extra-gynaecological surgical mesh, composite-polymer

GORE SYNECOR 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, composite-polymer.

Cleared under the same submission

K152609 also covers:

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 aa7d0090-d425-4967-9992-8986212b2025 37 fields · synced Jun 8, 2026