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Dr Paley’s Osteotomy System
EUDAMEDFDA UDIClass I (EU MDR)
Ref DRPO-708Model OSTEOTOME
Identity
- Trade Name
- Dr Paley’s Osteotomy System EUDAMEDDr.Paleys Osteotomy System FDA UDI
- Generic Name
- Orthopaedic osteotome FDA UDI
- Device Name
- Dr PALEY OSTEOTOME 8 mm FDA UDI
- Model / Reference
- OSTEOTOME EUDAMEDDRPO-708 EUDAMEDFDA UDI
- Description
- Dr PALEY OSTEOTOME 8 mm FDA UDI
Identifiers
- Catalog Number
- DRPO-708 FDA UDI
- Primary DI / UDI-DI
- 07540194010643 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194DRP-OSTT3S EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L090401 ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic osteotome FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dr Paley’s Osteotomy System by Orthopediatrics Canada Ulc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7540194DRP-OSTT3S | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OrthoPediatrics Canada ULC
- EUDAMED SRN
- CA-MF-000013010
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 89d44aab-d562-4cb6-b359-66da4df2d1aa 61 fields · synced Jul 9, 2026
- FDA UDI f10263c5-36a7-4ae7-a79a-cb3bafc113f0 36 fields · synced May 29, 2026