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5301110051

by Stryker Corp.

Ref 5301-110-051Model 08858251002049SG

5301110051 (5301-110-051) is a device classified as Class IIa in the EU and Class I in the US made by Stryker Corp., registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 08858251002049SG) and listed in FDA GUDID since 23 Sep 2018 (UDI-DI 07613153004271), 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 Number08858251002049SG Basic UDI-DI 07613153004271UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613153004271 UDI-DI Date23 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002049SG registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 07613153004271 listed 23 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613153004271
  2. Registered EUDAMED 08858251002049SG

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  • Withdrawn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
Heavy Duty Blades
Model / Ref / Catalog
08858251002049SG, 5301-110-051, 5301110051
Primary DI / UDI-DI
07613153004271
Basic UDI-DI
08858251002049SG
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 — 62.8 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858251002049SG
5301-110-051
GUDID
5301110051
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.

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)