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0400661000

by Stryker Corp.

Ref 0400-661-000Model 08858251002434SP

0400661000 is a device classified as Class I in the EU and Class II in the US made by Stryker Corp., registered in EUDAMED on 1 Aug 2026 (Basic UDI-DI 08858251002434SP) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 07613154128372), 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 Number08858251002434SP Basic UDI-DI 07613154128372UDI-DIDate1 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613154128372 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002434SP registered 1 Aug 2026 Active
  • FDA GUDID UDI-DI 07613154128372 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613154128372
  2. Registered EUDAMED 08858251002434SP

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  • Withdrawn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
Face splash shield, single-use
Device name
PPE sterile face shields
Model / Ref / Catalog
08858251002434SP EUDAMED
0400-661-000 EUDAMED
0400661000 GUDID
Primary DI / UDI-DI
07613154128372
Basic UDI-DI
08858251002434SP
FDA product code
FXX
EMDN code
T020699 Medical use face masks (excluding personal protective equipment - PPE) - other
GMDN term
Face splash shield, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4040
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
08858251002434SP
0400-661-000
GUDID
0400661000
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Face splash shield, single-use

Similar devices in this category

Other devices filed under MEDICAL USE FACE MASKS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE).

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)