6001-035-000
Ref 6001-035-000Model 08858250000528S2
6001-035-000 is a Class I device made by Stryker Leibinger, registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI 08858250000528S2) and listed in FDA GUDID since 31 Aug 2017 (UDI-DI 07613327371291), active as of 25 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number08858250000528S2 07613327371291 | Date1 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number07613327371291 | Date31 Aug 2017 | StatusListed |
Official records
- EUDAMED public site 08858250000528S2
- AccessGUDID record 07613327371291
Across registries
- EUDAMED Basic UDI-DI 08858250000528S2 registered 1 Oct 2026 Active
- FDA GUDID UDI-DI 07613327371291 listed 31 Aug 2017 Listed
Timeline
- Listed FDA GUDID 07613327371291
- Registered EUDAMED 08858250000528S2
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic name
- Device sterilization/disinfection container, reusable
- Device name
- Sterilization Trays
- Model / Ref / Catalog
- 6001-035-000, 08858250000528S2
- Primary DI / UDI-DI
- 07613327371291
- Basic UDI-DI
- 08858250000528S2
- Direct marketing DI
- 07613327371291
- FDA product code
- FSM
- EMDN code
- Z12011480 Surgical navigation instruments - hardware accessories
- GMDN term
- Device sterilization/disinfection container, reusable
- Device class
- Class I
- Regulation number
- 878.4800
- EU registration type
- Standard device
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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