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GORE-TEX Suture 3N04

by W. L. Gore & Associates, Inc.

Ref 3N04

GORE-TEX Suture 3N04 is a device classified as Class III in the EU and Class II in the US made by W. L. Gore & Associates, Inc., registered in EUDAMED on 12 May 2026 (Basic UDI-DI B-00733132628698), approved under FDA PMA P820083 on 12 May 1986 and listed in FDA GUDID since 13 Feb 2017 (UDI-DI 00733132628698), withdrawn (EUDAMED), active (FDA PMA) as of 23 Oct 2026.

Active Active in United States. Withdrawn in European Union. Also listed in GUDID (US).

CE MDD, withdrawn PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

PMA P820083

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00733132628698 Basic UDI-DI 00733132628698UDI-DIDate12 May 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number00733132628698 UDI-DI Date13 Feb 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP820083 Date12 May 1986DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00733132628698 registered 12 May 2026 Withdrawn
  • FDA PMA P820083 decided 12 May 1986 Active
  • FDA GUDID UDI-DI 00733132628698 listed 13 Feb 2017 Listed

Timeline

3 dated events

  1. Approved FDA PMA P820083
  2. Listed FDA GUDID 00733132628698
  3. Registered EUDAMED B-00733132628698

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDD Withdrawn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

Specification

EUDAMED · GUDID

Trade name
GORE-TEX Suture
Generic name
Polyolefin/fluoropolymer suture, monofilament
Model / Ref / Catalog
3N04
Primary DI / UDI-DI
00733132628698
Basic UDI-DI
B-00733132628698
PMA number
FDA product code
GAW
EMDN code
H010201010501 Polytetrafluoroethylene (ptfe) monofilament with needle
GMDN term
Polyolefin/fluoropolymer suture, monofilament
Device class
Class III EUDAMED
Class II GUDID
Regulation number
878.5010
EU registration type
Legacy device (under a directive)
GUDID distribution status
In Commercial Distribution
Size
Length — 91 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Polyolefin/fluoropolymer suture, monofilament

Cleared under the same submission (P820083)

and 8 more cleared under P820083

Similar devices in this category

Other devices filed under POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE.

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

See all devices from W. L. Gore & Associates, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)