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6001-021-000

by Stryker Leibinger

Ref 6001-021-000Model 08858251005719TX

6001-021-000 is a device classified as Class III in the EU and Class II in the US made by Stryker Leibinger, registered in EUDAMED on 19 Oct 2026 (Basic UDI-DI 08858251005719TX) and listed in FDA GUDID since 14 Sep 2016 (UDI-DI 04546540245793), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

13 May 2029

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier TÜV Rheinland LGA Products GmbH

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251005719TX Basic UDI-DI 04546540245793UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04546540245793 UDI-DI Date14 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251005719TX registered 19 Oct 2026 Active
  • FDA GUDID UDI-DI 04546540245793 listed 14 Sep 2016 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Timeline

2 dated events

  1. Listed FDA GUDID 04546540245793
  2. Registered EUDAMED 08858251005719TX

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Stereotactic surgery system probe, reusable
Device name
FP5000 Class III Pointers for Cranial
Model / Ref / Catalog
6001-021-000, 08858251005719TX
Primary DI / UDI-DI
04546540245793
Basic UDI-DI
08858251005719TX
Direct marketing DI
04546540245793
FDA product code
HAW
EMDN code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN term
Stereotactic surgery system probe, reusable
Device class
Class III EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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: Stereotactic surgery system probe, reusable

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES.

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Properties

  • Sterilise before use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)