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5230010090

by Stryker Corp.

Ref 5230-010-090Model 08858251002064SC

5230010090 (5230-010-090) is a cranial bur (EU MDR Class IIa; FDA Class II; FDA product code HBE, Drills, Burrs, Trephines & Accessories (Simple, Powered)) made by Stryker Corp., registered in EUDAMED on 31 Oct 2026 (Basic UDI-DI 08858251002064SC) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 07613154409907), 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 Number08858251002064SC Basic UDI-DI 07613154409907UDI-DIDate31 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613154409907 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002064SC registered 31 Oct 2026 Active
  • FDA GUDID UDI-DI 07613154409907 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613154409907
  2. Registered EUDAMED 08858251002064SC

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  • Withdrawn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
Cranial bur, single-use
Device name
Round Fluted
Model / Ref / Catalog
08858251002064SC, 5230-010-090, 5230010090
Primary DI / UDI-DI
07613154409907
Basic UDI-DI
08858251002064SC
FDA product code
HBE
EMDN code
V0199 Cutting devices, single-use - other
GMDN term
Cranial bur, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4310
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858251002064SC
5230-010-090
GUDID
5230010090
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: Cranial bur, single-use

Similar devices in this category

Other devices filed under CUTTING DEVICES, SINGLE-USE - OTHER.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)