5407-350-000
Ref 5407-350-000Model 08858251002427SS
5407-350-000 is a device classified as Class IIa in the EU and Class II in the US made by Stryker Corp., registered in EUDAMED on 23 Jun 2026 (Basic UDI-DI 08858251002427SS) and listed in FDA GUDID since 8 Jul 2021 (UDI-DI 07613327504057), active as of 2 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 | Number08858251002427SS 07613327504057 | Date23 Jun 2026 | StatusActive |
| United States | GUDID listing GUDID | Number07613327504057 | Date8 Jul 2021 | StatusListed |
Official records
- EUDAMED public site 08858251002427SS
- AccessGUDID record 07613327504057
Across registries
- EUDAMED Basic UDI-DI 08858251002427SS registered 23 Jun 2026 Active
- FDA GUDID UDI-DI 07613327504057 listed 8 Jul 2021 Listed
Timeline
- Listed FDA GUDID 07613327504057
- Registered EUDAMED 08858251002427SS
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic name
- Bone/joint surgical power tool motor, electric
- Device name
- Reusable High Speed Surgical Drills
- Model / Ref / Catalog
- 5407-350-000, 08858251002427SS
- Primary DI / UDI-DI
- 07613327504057
- Basic UDI-DI
- 08858251002427SS
- Direct marketing DI
- 07613327504057
- FDA product code
- OLO, ERL, DZJ, HBE
- EMDN code
- Z12019080 Various instruments for general and multidisciplinary surgery - hardware accessories
- GMDN term
- Bone/joint surgical power tool motor, electric
- Device class
- Class IIa EUDAMEDClass II GUDID
- Regulation number
- 882.4560, 874.4250, 872.4120, 882.4310
- EU registration type
- Standard device
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class IIa | Class II |
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