0210012000
Ref 0210-012-000Model 08858251004423SY
0210012000 (0210-012-000) is a device classified as Class IIa in the EU and Class II in the US made by Stryker Corp., registered in EUDAMED on 24 Oct 2026 (Basic UDI-DI 08858251004423SY) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04546540144171), 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 | Number08858251004423SY 04546540144171 | Date24 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number04546540144171 | Date23 Sep 2016 | StatusListed |
Official records
- EUDAMED public site 08858251004423SY
- AccessGUDID record 04546540144171
Across registries
- EUDAMED Basic UDI-DI 08858251004423SY registered 24 Oct 2026 Active
- FDA GUDID UDI-DI 04546540144171 listed 23 Sep 2016 Listed
Timeline
- Listed FDA GUDID 04546540144171
- Registered EUDAMED 08858251004423SY
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic name
- Surgical irrigation system nozzle
- Device name
- InterPulse Tips
- Model / Ref / Catalog
- 08858251004423SY, 0210-012-000, 0210012000
- Primary DI / UDI-DI
- 04546540144171
- Basic UDI-DI
- 08858251004423SY
- FDA product code
- FQH
- EMDN code
- Z12019003 Wound treatment equipment
- GMDN term
- Surgical irrigation system nozzle
- Device class
- Class IIa EUDAMEDClass II GUDID
- Regulation number
- 880.5475
- EU registration type
- Standard device
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / reference | 08858251004423SY 0210-012-000 | 0210012000 |
| Device class | Class IIa | Class II |