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5290647000

by Stryker Corp.

Ref 5290-647-000Model 08858251002036S7

5290647000 (5290-647-000) is a device classified as Class IIa in the EU and Class II in the US made by Stryker Corp., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 08858251002036S7) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04546540427939), 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 Number08858251002036S7 Basic UDI-DI 04546540427939UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04546540427939 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002036S7 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 04546540427939 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04546540427939
  2. Registered EUDAMED 08858251002036S7

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  • Withdrawn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
ESSx
Generic name
Diamond ENT bur, single-use
Device name
Hummer Cutters
Model / Ref / Catalog
08858251002036S7, 5290-647-000, 5290647000
Primary DI / UDI-DI
04546540427939
Basic UDI-DI
08858251002036S7
FDA product code
ERL
EMDN code
V010302 Blades without safety systems, single-use - not included in other classes
GMDN term
Diamond ENT bur, single-use
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
Size
Length — 8.0 Centimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858251002036S7
5290-647-000
GUDID
5290647000
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: Diamond ENT bur, single-use

Similar devices in this category

Other devices filed under BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES.

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)