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Operon Oz 7518475

by STRYKER Communications, Inc.

Ref OZ 7518475Model 08858250000764SG

Operon Oz 7518475 is a Class I device made by STRYKER Communications, Inc., registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI 08858250000764SG) and listed in FDA GUDID since 24 Jan 2019 (UDI-DI 07613327170474), 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 Number08858250000764SG Basic UDI-DI 07613327170474UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327170474 UDI-DI Date24 Jan 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858250000764SG registered 5 Nov 2026 Active
  • FDA GUDID UDI-DI 07613327170474 listed 24 Jan 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327170474
  2. Registered EUDAMED 08858250000764SG

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  • Withdrawn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
Operon
Generic name
X-ray film cassette holder
Device name
COM_TF10469_X-Ray Cassette Tray
Model / Ref / Catalog
OZ 7518475, 08858250000764SG
Primary DI / UDI-DI
07613327170474
Basic UDI-DI
08858250000764SG
Direct marketing DI
07613327170474
FDA product code
GDC
EMDN code
Z12011280 Patient positioning instruments - hardware accessories
GMDN term
X-ray film cassette holder
Device class
Class I
Regulation number
878.4960
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Related devices

Category: X-ray film cassette holder

Similar devices in this category

Other devices filed under PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from STRYKER Communications, Inc.

See all devices from STRYKER Communications, Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)