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5820009060

by Stryker Corp.

Ref 5820-009-060Model 08858251002034S3

5820009060 (5820-009-060) 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 08858251002034S3) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04546540670106), 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 Number08858251002034S3 Basic UDI-DI 04546540670106UDI-DIDate31 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04546540670106 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002034S3 registered 31 Oct 2026 Active
  • FDA GUDID UDI-DI 04546540670106 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04546540670106
  2. Registered EUDAMED 08858251002034S3

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  • Withdrawn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
Precision Round - Elite
Model / Ref / Catalog
08858251002034S3, 5820-009-060, 5820009060
Primary DI / UDI-DI
04546540670106
Basic UDI-DI
08858251002034S3
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
08858251002034S3
5820-009-060
GUDID
5820009060
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)