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VV-Plug 667145-302

by Oscor Inc.

Ref VV-PLUGModel 7145

VV-Plug 667145-302 is a device classified as Class III in the EU and Class II in the US made by Oscor Inc., registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI B-00885672008291), cleared under FDA 510(k) K031164 on 19 Jun 2003 and listed in FDA GUDID since 15 Nov 2017 (UDI-DI 00885672008291), active as of 24 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K031164

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00885672008291 Basic UDI-DI 00885672008291UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00885672008291 UDI-DI Date15 Nov 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)ST GUDID from GUDID Special NumberK031164 Date19 Jun 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00885672008291 registered 20 Oct 2026 Active
  • FDA 510(k) K031164 decided 19 Jun 2003 Active
  • FDA GUDID UDI-DI 00885672008291 listed 15 Nov 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K031164
  2. Listed FDA GUDID 00885672008291
  3. Registered EUDAMED B-00885672008291

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Port Plug EUDAMED
VV-Plug GUDID
Generic name
Implantable pulse generator port plug
Model / Ref / Catalog
7145, VV-PLUG, 667145-302
Primary DI / UDI-DI
00885672008291
Basic UDI-DI
B-00885672008291
510(k) Number
FDA product code
DTD
EMDN code
C020180 Cardiac electrophysiology and mapping devices - accessories
GMDN term
Implantable pulse generator port plug
Device class
Class III EUDAMED
Class II GUDID
Regulation number
870.3620
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 3.2 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
7145
VV-PLUG
GUDID
667145-302
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: Implantable pulse generator port plug

Cleared under the same submission (K031164)

Similar devices in this category

Other devices filed under CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - ACCESSORIES.

Other devices from Oscor Inc.

See all devices from Oscor Inc. →

Properties

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