Prospace
Ref SJ217R, SJ221R, SJ220P, SJ222P, SJ217P, SJ883R, SJ801R, SJ219P
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4039239000000430ZR | Date18 Nov 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- PROSPACE/TSPACE distractorPROSPACE/TSPACE implantation instr. IIaPROSPACE/TSPACE dissecting instrumentPROSPACE/TSPACE instrument tray
- Model / Reference
- SJ217R, SJ221R, SJ220P, SJ222P, SJ217P, SJ883R, SJ801R, SJ219P
- Primary DI / UDI-DI
- 04046963775544, 04046963775582, 04046963775117, 04046963775131, 04046963775087, 04046963955182, 04046963954987, 04046963775100
- Basic UDI-DI
- 4039239000000430ZR, 40392390000006382N, 4039239000000431ZT, 40392390000006192J
- Direct Marketing DI
- 0404696377554404046963775582040469637751170404696377513104046963775087040469639551820404696395498704046963775100
- EMDN Code
- L091199, S010401
- Device Class
- Class IClass IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000005504
Other devices from Aesculap AG
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No