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IS4/DF4 Plug

by Oscor Inc.

Ref IS4/DF4 PLUGModel IS4/DF4

IS4/DF4 Plug 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-00885672007003), cleared under FDA 510(k) K143463 on 19 Mar 2015 and listed in FDA GUDID since 16 Oct 2015 (UDI-DI 00885672007003), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K143463

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00885672007003 Basic UDI-DI 00885672007003UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00885672007003 UDI-DI Date16 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK143463 Date19 Mar 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00885672007003 registered 20 Oct 2026 Active
  • FDA 510(k) K143463 decided 19 Mar 2015 Active
  • FDA GUDID UDI-DI 00885672007003 listed 16 Oct 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K143463
  2. Listed FDA GUDID 00885672007003
  3. Registered EUDAMED B-00885672007003

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  • Withdrawn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
IS4/DF4 Plug GUDID
Generic name
Implantable pulse generator port plug
Model / reference
IS4/DF4 PLUG, IS4/DF4
Primary DI / UDI-DI
00885672007003
Basic UDI-DI
B-00885672007003
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

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: Implantable pulse generator port plug

Cleared under the same submission (K143463)

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)