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Dr Paley’s Osteotomy System
EUDAMEDFDA UDIClass I (EU MDR)
Ref DRPF-601Model FASCIOTOME
Identity
- Trade Name
- Dr Paley’s Osteotomy System EUDAMEDDr.Paleys Osteotomy System FDA UDI
- Generic Name
- Scalpel, reusable FDA UDI
- Device Name
- Dr PALEY FASCIOTOME FDA UDI
- Model / Reference
- FASCIOTOME EUDAMEDDRPF-601 EUDAMEDFDA UDI
- Description
- Dr PALEY FASCIOTOME FDA UDI
Identifiers
- Catalog Number
- DRPF-601 FDA UDI
- Primary DI / UDI-DI
- 07540194010551 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194DRP-FSTUZ EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L090903 ORTHOPAEDIC SURGERY SCALPELS AND KNIVES, REUSABLE EUDAMED
- GMDN Term
- Scalpel, 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-FSTUZ | 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 8a4ce2d0-2f83-4790-a045-78a50511e2bb 61 fields · synced Jun 8, 2026
- FDA UDI cfaa6d00-0849-4acc-8c94-8d7bbf97e4e5 36 fields · synced May 30, 2026