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6002-190-030

by Stryker Leibinger

Ref 6002-190-030Model 08858250000547S6

6002-190-030 is a device classified as Class IIa in the EU and Class II in the US made by Stryker Leibinger, registered in EUDAMED on 25 Oct 2026 (Basic UDI-DI 08858250000547S6) and listed in FDA GUDID since 6 Dec 2017 (UDI-DI 07613327353624), active as of 7 Nov 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858250000547S6 Basic UDI-DI 07613327353624UDI-DIDate25 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327353624 UDI-DI Date6 Dec 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858250000547S6 registered 25 Oct 2026 Active
  • FDA GUDID UDI-DI 07613327353624 listed 6 Dec 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327353624
  2. Registered EUDAMED 08858250000547S6

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  • Withdrawn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
Fluted surgical drill bit, single-use
Device name
Navigated Drill Bit
Model / Ref / Catalog
6002-190-030, 08858250000547S6
Primary DI / UDI-DI
07613327353624
Basic UDI-DI
08858250000547S6
FDA product code
OLO
EMDN code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN term
Fluted surgical drill bit, single-use
Device class
Class IIa 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 IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Fluted surgical drill bit, single-use

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Stryker Leibinger

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  • 92-55770

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See all devices from Stryker Leibinger →

Properties

  • Sterilise before use
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Measuring function
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)