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5450400000

by Stryker Corp.

Ref 5450-400-000Model 08858251002427SS

5450400000 (5450-400-000) is a device classified as Class IIa in the EU and Class II in the US made by Stryker Corp., registered in EUDAMED on 23 Jun 2026 (Basic UDI-DI 08858251002427SS) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 07613252468356), 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 Number08858251002427SS Basic UDI-DI 07613252468356UDI-DIDate23 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613252468356 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002427SS registered 23 Jun 2026 Active
  • FDA GUDID UDI-DI 07613252468356 listed 24 Sep 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613252468356
  2. Registered EUDAMED 08858251002427SS

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  • Withdrawn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/joint surgical power tool motor, electric
Device name
Reusable High Speed Surgical Drills
Model / Ref / Catalog
08858251002427SS, 5450-400-000, 5450400000
Primary DI / UDI-DI
07613252468356
Basic UDI-DI
08858251002427SS
FDA product code
ERL
EMDN code
Z12019080 Various instruments for general and multidisciplinary surgery - hardware accessories
GMDN term
Bone/joint surgical power tool motor, electric
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.4250
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858251002427SS
5450-400-000
GUDID
5450400000
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: Bone/joint surgical power tool motor, electric

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - HARDWARE ACCESSORIES.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (22, all answered No)