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Fassier-Duval Telescopic Im System
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref TRP164Model TREPHINE
Identity
- Trade Name
- The Fassier-Duval Telescopic IM System EUDAMEDFASSIER-DUVAL TELESCOPIC IM SYSTEM FDA UDI
- Generic Name
- Bone trephine, reusable FDA UDI
- Device Name
- TREPHINE 6.4mm FDA UDI
- Model / Reference
- TRP164 EUDAMEDFDA UDITREPHINE EUDAMED
- Description
- TREPHINE 6.4mm FDA UDI
Identifiers
- Catalog Number
- TRP164 FDA UDI
- Primary DI / UDI-DI
- 07540194007636 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194FD-TRS6 EUDAMED
- FDA Product Code
- HWK FDA UDI
- EMDN Code
- L090902 ORTHOPAEDIC SURGERY TREPHINES, REUSABLE EUDAMED
- GMDN Term
- Bone trephine, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 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
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Dimensions & Sizes
- Size
- Length — 466 Millimeter FDA UDIOuter Diameter — 6.4 Millimeter FDA UDILumen/Inner Diameter — 4.29 Millimeter FDA UDI
Category: Bone trephine, reusable
Fassier-Duval Telescopic Im System by Orthopediatrics Canada ULC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Bone trephine, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Orthopediatrics Canada ULC
Sources (2)
- FDA UDI 8bc583f0-db2e-46d1-9c55-3b4691dbb96f 37 fields · synced Jun 19, 2026
- EUDAMED 977cf512-b93c-43e1-b56d-748409174560 61 fields · synced Jun 19, 2026