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Formula 0375545000

by Stryker Corp.

Part of a family of 46 devices: see the family page

Ref 0375-545-000Model 08858251003368TA

Formula 0375545000 (0375-545-000) is a device classified as Class IIa in the EU and Class I in the US made by Stryker Corp., registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI 08858251003368TA) and listed in FDA GUDID since 12 Sep 2018 (UDI-DI 07613327061796), 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 Number08858251003368TA Basic UDI-DI 07613327061796UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327061796 UDI-DI Date12 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251003368TA registered 23 Oct 2026 Active
  • FDA GUDID UDI-DI 07613327061796 listed 12 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327061796
  2. Registered EUDAMED 08858251003368TA

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  • Withdrawn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
Formula
Generic name
Arthroscopic shaver system, electrically-powered
Device name
SMBU_TF10458_Shavers and Cutters
Model / Ref / Catalog
08858251003368TA, 0375-545-000, 0375545000
Description
[Tomcat Cutter, Arthroscopic Shaver Blade, Do Not Resterilize, Do Not Use if Package is Damaged, Keep Dry, Keep Away from Sunlight]
Primary DI / UDI-DI
07613327061796
Basic UDI-DI
08858251003368TA
FDA product code
GFA
EMDN code
K030203 Arthroscopy blades, single-use
GMDN term
Arthroscopic shaver system, electrically-powered
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Length — 125.0 Millimeter
Outer Diameter — 4.0 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858251003368TA
0375-545-000
GUDID
0375545000
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: Arthroscopic shaver system, electrically-powered

Similar devices in this category

Other devices filed under ARTHROSCOPY BLADES, SINGLE-USE.

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
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)