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01-03492

by Stryker Leibinger

Ref 01-03492Model 08858251006147TD

01-03492 is a device classified as Class IIa in the EU and Class II in the US made by Stryker Leibinger, registered in EUDAMED on 30 Jul 2026 (Basic UDI-DI 08858251006147TD) and listed in FDA GUDID since 6 Jul 2015 (UDI-DI 37613153154281), active as of 25 Oct 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251006147TD Basic UDI-DI 37613153154281UDI-DIDate30 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number37613153154281 UDI-DI Date6 Jul 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251006147TD registered 30 Jul 2026 Active
  • FDA GUDID UDI-DI 37613153154281 listed 6 Jul 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 37613153154281
  2. Registered EUDAMED 08858251006147TD

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  • Withdrawn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
Bone holding forceps
Device name
Universal HMMF and MMF Ligature Wires
Model / Ref / Catalog
01-03492, 08858251006147TD
Primary DI / UDI-DI
37613153154281
Basic UDI-DI
08858251006147TD
Unit of use DI
07613153154280
FDA product code
JEY
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Bone holding forceps
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.4760
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Needle Gauge — 22.0 Gauge
Length — 16.0 Centimeter
Length — 160.0 Millimeter

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: Maxillofacial bone wire/bar

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES.

Other devices from Stryker Leibinger

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Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)