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Dr Paley’s Osteotomy System
EUDAMEDFDA UDIClass I (EU MDR)
Ref DRPRAC-201Model CLAMP
Identity
- Trade Name
- Dr Paley’s Osteotomy System EUDAMEDDr.Paleys Osteotomy System FDA UDI
- Generic Name
- Dressing/utility forceps, scissors-like, reusable FDA UDI
- Device Name
- Dr PALEY RIGHT ANGLE CLAMP FDA UDI
- Model / Reference
- CLAMP EUDAMEDDRPRAC-201 EUDAMEDFDA UDI
- Description
- Dr PALEY RIGHT ANGLE CLAMP FDA UDI
Identifiers
- Catalog Number
- DRPRAC-201 FDA UDI
- Primary DI / UDI-DI
- 07540194010681 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194DRP-CCS4 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091103 ORTHOPAEDIC PROSTHESES FORCEPS, REUSABLE EUDAMED
- GMDN Term
- Dressing/utility forceps, scissors-like, reusable 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-CCS4 | 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 a74c6013-7875-4300-91a4-288616d60c80 61 fields · synced Jul 13, 2026
- FDA UDI 928750d8-447c-4192-98ad-5620a41a1466 36 fields · synced May 27, 2026