Dr.Paleys Osteotomy System DRPCP-201
Ref DRPCP-201Model PIN
Dr.Paleys Osteotomy System DRPCP-201 is a Class I device made by Orthopediatrics Canada ULC, registered in EUDAMED on 29 Oct 2024 (Basic UDI-DI 7540194DRP-PINV9) and listed in FDA GUDID since 11 Sep 2024 (UDI-DI 07540194016041), active as of 23 Oct 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 | Number7540194DRP-PINV9 07540194016041 | Date29 Oct 2024 | StatusActive |
| United States | GUDID listing GUDID | Number07540194016041 | Date11 Sep 2024 | StatusListed |
Official records
- EUDAMED public site 7540194DRP-PINV9
- AccessGUDID record 07540194016041
Across registries
- EUDAMED Basic UDI-DI 7540194DRP-PINV9 registered 29 Oct 2024 Active
- FDA GUDID UDI-DI 07540194016041 listed 11 Sep 2024 Listed
Timeline
- Listed FDA GUDID 07540194016041
- Registered EUDAMED 7540194DRP-PINV9
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Dr Paley’s Osteotomy System EUDAMEDDr.Paleys Osteotomy System GUDID
- Generic name
- Orthopaedic instrument surgical connector
- Model / Ref / Catalog
- DRPCP-201, PIN
- Primary DI / UDI-DI
- 07540194016041
- Basic UDI-DI
- 7540194DRP-PINV9
- FDA product code
- LXH
- EMDN code
- L098099 Orthopaedic and traumatological surgery instruments, reusable - other accessories
- GMDN term
- Orthopaedic instrument surgical connector
- Device class
- Class I
- Regulation number
- 888.4540
- EU registration type
- Standard device
- EU market of registration
- Sweden
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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