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The Fassier-Duval Telescopic IM System
EUDAMEDFDA UDIClass I (EU MDR)
Ref PRO148-156Model PROBE
Identity
- Trade Name
- The Fassier-Duval Telescopic IM System EUDAMEDFASSIER-DUVAL TELESCOPIC IM SYSTEM FDA UDI
- Generic Name
- Bone nail trial, reusable FDA UDI
- Device Name
- PROBE Ø4.8mm AND Ø5.6mm FDA UDI
- Model / Reference
- PROBE EUDAMEDPRO148-156 EUDAMEDFDA UDI
- Description
- PROBE Ø4.8mm AND Ø5.6mm FDA UDI
Identifiers
- Catalog Number
- PRO148-156 FDA UDI
- Primary DI / UDI-DI
- 07540194007179 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194FD-PRBMB EUDAMED
- FDA Product Code
- HTJ FDA UDI
- EMDN Code
- L098099 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Bone nail trial, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4300 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
Yes
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
The Fassier-Duval Telescopic IM 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 | 7540194FD-PRBMB | 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 4d2516e4-63a5-4aaf-89c0-b89d8d6f15b1 61 fields · synced Jul 25, 2026
- FDA UDI 75bed4d1-d32c-46e2-8c55-9b6c8da5f560 36 fields · synced May 29, 2026