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5400-800-000

by Stryker Corp.

Ref 5400-800-000Model 08858251002066SG

5400-800-000 is a device classified as Class IIa in the EU and Class II in the US made by Stryker Corp., registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI 08858251002066SG) and listed in FDA GUDID since 12 Jun 2020 (UDI-DI 07613327502985), 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 Number08858251002066SG Basic UDI-DI 07613327502985UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327502985 UDI-DI Date12 Jun 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002066SG registered 25 Sep 2026 Active
  • FDA GUDID UDI-DI 07613327502985 listed 12 Jun 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327502985
  2. Registered EUDAMED 08858251002066SG

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  • Withdrawn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 graft harvesting filter
Device name
Bone Dust Collector
Model / Ref / Catalog
5400-800-000, 08858251002066SG
Primary DI / UDI-DI
07613327502985
Basic UDI-DI
08858251002066SG
FDA product code
BYZ
EMDN code
A0499 Solution filters - other
GMDN term
Bone graft harvesting filter
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.6740
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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 graft harvesting filter

Similar devices in this category

Other devices filed under SOLUTION FILTERS - OTHER.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)