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92-06764

by Stryker Leibinger

Ref 92-06764Model 08858251001892TJ

92-06764 is a device classified as Class I in the EU and Class II in the US made by Stryker Leibinger, registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI 08858251001892TJ) and listed in FDA GUDID since 16 Jun 2015 (UDI-DI 07613154186129), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251001892TJ Basic UDI-DI 07613154186129UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613154186129 UDI-DI Date16 Jun 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251001892TJ registered 14 Oct 2026 Active
  • FDA GUDID UDI-DI 07613154186129 listed 16 Jun 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613154186129
  2. Registered EUDAMED 08858251001892TJ

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  • Withdrawn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
Surgical implant template, single-use
Device name
Universal - Upperface module 1.2/Universal - Midface module 1.7 Others
Model / Ref / Catalog
92-06764, 08858251001892TJ
Primary DI / UDI-DI
07613154186129
Basic UDI-DI
08858251001892TJ
FDA product code
JEY
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Surgical implant template, single-use
Device class
Class I 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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Surgical implant template, single-use

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)