6000-006-000
Ref 6000-006-000Model 08858250000553RZ
6000-006-000 is a device classified as Class I in the EU and Class II in the US made by Stryker Leibinger, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 08858250000553RZ) and listed in FDA GUDID since 24 Aug 2016 (UDI-DI 04546540245045), active as of 7 Nov 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 | Number08858250000553RZ 04546540245045 | Date29 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number04546540245045 | Date24 Aug 2016 | StatusListed |
Official records
- EUDAMED public site 08858250000553RZ
- AccessGUDID record 04546540245045
Across registries
- EUDAMED Basic UDI-DI 08858250000553RZ registered 29 Oct 2026 Active
- FDA GUDID UDI-DI 04546540245045 listed 24 Aug 2016 Listed
Timeline
- Listed FDA GUDID 04546540245045
- Registered EUDAMED 08858250000553RZ
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic name
- Primary battery
- Model / Ref / Catalog
- 6000-006-000, 08858250000553RZ
- Primary DI / UDI-DI
- 04546540245045
- Basic UDI-DI
- 08858250000553RZ
- FDA product code
- OLO, HAW
- EMDN code
- Z12011485 Surgical navigation instruments - consumables
- GMDN term
- Primary battery
- Device class
- Class I EUDAMEDClass II GUDID
- Regulation number
- 882.4560
- EU registration type
- Standard device
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class I | Class II |
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