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GORE-TEX Soft Tissue Patch 1405010010

by W. L. Gore & Associates, Inc.

Ref 1405010010Model 1315020020

Withdrawn Withdrawn in European Union.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00733132600564 Basic UDI-DI 00733132600564UDI-DIDate8 May 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number00733132600564 UDI-DI Date26 Jan 2017ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Withdrawn
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
GORE-TEX® Soft Tissue Patch EUDAMED
GORE-TEX Soft Tissue Patch GUDID
Generic Name
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Model / Ref / Catalog
1405010010, 1315020020
Primary DI / UDI-DI
00733132600564
Basic UDI-DI
B-00733132600564
510(k) Number
FDA Product Code
FTL
EMDN Code
P900203 Ptfe surgical meshes
GMDN Term
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.3300
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe
Size
Height — 1 Millimeter
Length — 10 Centimeter
Width — 5 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K963619)

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Other devices from W. L. Gore & Associates, Inc.

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No