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07-10006

by Stryker Corp.

Ref 07-10006Model 08858251002740SZ

07-10006 is a Class I device made by Stryker Corp., registered in EUDAMED on 24 Sep 2026 (Basic UDI-DI 08858251002740SZ) and listed in FDA GUDID since 24 Sep 2020 (UDI-DI 04546540540645), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002740SZ Basic UDI-DI 04546540540645UDI-DIDate24 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04546540540645 UDI-DI Date24 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002740SZ registered 24 Sep 2026 Active
  • FDA GUDID UDI-DI 04546540540645 listed 24 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04546540540645
  2. Registered EUDAMED 08858251002740SZ

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  • Withdrawn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

Trade name
VariAx
Generic name
Orthopaedic surgical procedure kit, non-medicated, reusable
Device name
Variax Instruments - Distraction / Retraction Instrumentation - Class I - Reusable - Non Sterile
Model / Ref / Catalog
07-10006, 08858251002740SZ
Primary DI / UDI-DI
04546540540645
Basic UDI-DI
08858251002740SZ
Direct marketing DI
04546540540645
FDA product code
LXH
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic surgical procedure kit, non-medicated, reusable

Similar devices in this category

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

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

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