PBS WEDGE - Osteotomy burr 3, 1x13 mm
Ref 400.1101Model PBS
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 | Number8056693050AP 08056693000058 | Date26 Aug 2026 | 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- Withdrawn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
- PBS - Burr
- Model / Reference
- PBS, 400.1101
- Primary DI / UDI-DI
- 08056693000058
- Basic UDI-DI
- 8056693050AP
- EMDN Code
- P091301 Orthopaedic implant reamers, single-use
- Device Class
- Class IIa
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000005991
Other devices from Intrauma S.p.A.
Properties
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No