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5400031032S1

by Stryker Corp.

Ref 5400-031-032S1Model 08858251002010RM

5400031032S1 (5400-031-032S1) is a device classified as Class IIa in the EU and Class I in the US made by Stryker Corp., registered in EUDAMED on 17 Sep 2026 (Basic UDI-DI 08858251002010RM) and listed in FDA GUDID since 23 Sep 2018 (UDI-DI 07613154014521), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002010RM Basic UDI-DI 07613154014521UDI-DIDate17 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613154014521 UDI-DI Date23 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002010RM registered 17 Sep 2026 Active
  • FDA GUDID UDI-DI 07613154014521 listed 23 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613154014521
  2. Registered EUDAMED 08858251002010RM

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  • Withdrawn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
Surgical saw blade, sagittal, single-use
Device name
IBO/IOB Blades
Model / Ref / Catalog
08858251002010RM, 5400-031-032S1, 5400031032S1
Primary DI / UDI-DI
07613154014521
Basic UDI-DI
08858251002010RM
FDA product code
GFA
EMDN code
V010302 Blades without safety systems, single-use - not included in other classes
GMDN term
Surgical saw blade, sagittal, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Depth — 3.7 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858251002010RM
5400-031-032S1
GUDID
5400031032S1
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Surgical saw blade, sagittal, 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
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)