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GORE DUALMESH Biomaterial 1DLMC203

by W. L. Gore & Associates, Inc.

Ref 1DLMC203

Withdrawn Withdrawn in European Union.

Was authorized under CE MDD, withdrawn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Withdrawn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-00733132601066 Basic UDI-DI 00733132601066UDI-DIDate8 May 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number00733132601066 UDI-DI Date7 Mar 2016ListedStatusListed 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  • Withdrawn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  • European Union CE/MDD Withdrawn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® DUALMESH® Biomaterial EUDAMED
GORE DUALMESH Biomaterial GUDID
Generic Name
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Model / Ref / Catalog
1DLMC203
Primary DI / UDI-DI
00733132601066
Basic UDI-DI
B-00733132601066
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
Length — 30 Centimeter
Width — 20 Centimeter
Height — 2 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K992189)

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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