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6007-004-100

by Stryker Leibinger

Ref 6007-004-100Model 08858250000572S5

6007-004-100 is a device classified as Class IIa in the EU and Class II in the US made by Stryker Leibinger, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI 08858250000572S5) and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 37613154107415), 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 Number08858250000572S5 Basic UDI-DI 37613154107415UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number37613154107415 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858250000572S5 registered 6 Nov 2026 Active
  • FDA GUDID UDI-DI 37613154107415 listed 20 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 37613154107415
  2. Registered EUDAMED 08858250000572S5

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  • Withdrawn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
Orthopaedic bone pin, non-bioabsorbable
Device name
Navigation Pins
Model / Ref / Catalog
6007-004-100, 08858250000572S5
Primary DI / UDI-DI
37613154107415
Basic UDI-DI
08858250000572S5
Unit of use DI
07613154107414
FDA product code
HAW, OLO
EMDN code
Z12011485 Surgical navigation instruments - consumables
GMDN term
Orthopaedic bone pin, non-bioabsorbable
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
Size
Length — 100.0 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

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: Orthopaedic bone pin, non-bioabsorbable

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES.

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Properties

  • Supplied sterile
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)