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C2C 4607300032

by Stryker Corp.

Ref 4607-300-032Model 08858251004538TJ

C2C 4607300032 (4607-300-032) is a surgical depth gauge (EU MDR Class IIa; FDA Class I; FDA product code HWE, Instrument, Surgical, Orthopedic, Ac-Powered Motor and Accessory/Attachment) made by Stryker Corp., registered in EUDAMED on 14 Sep 2026 (Basic UDI-DI 08858251004538TJ) and listed in FDA GUDID since 6 Sep 2022 (UDI-DI 07613327555301), 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 Number08858251004538TJ Basic UDI-DI 07613327555301UDI-DIDate14 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327555301 UDI-DI Date6 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251004538TJ registered 14 Sep 2026 Active
  • FDA GUDID UDI-DI 07613327555301 listed 6 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327555301
  2. Registered EUDAMED 08858251004538TJ

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  • Withdrawn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
C2C
Generic name
Surgical depth gauge, single-use
Model / Ref / Catalog
08858251004538TJ, 4607-300-032, 4607300032
Primary DI / UDI-DI
07613327555301
Basic UDI-DI
08858251004538TJ
FDA product code
HWE
EMDN code
Z12130599 Motorised orthopaedic surgery system instruments - other
GMDN term
Surgical depth gauge, 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

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
08858251004538TJ
4607-300-032
GUDID
4607300032
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 depth gauge, single-use

Similar devices in this category

Other devices filed under MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - OTHER.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Supplied sterile
  • Single use
  • Measuring function
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)