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Fassier-Duval Telescopic Im System
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref GIN-DCA026Model DRILL
Identity
- Trade Name
- The Fassier-Duval Telescopic IM System EUDAMEDFASSIER-DUVAL TELESCOPIC IM SYSTEM FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- REAMER Ø2.6mm FDA UDI
- Model / Reference
- GIN-DCA026 EUDAMEDFDA UDIDRILL EUDAMED
- Description
- REAMER Ø2.6mm FDA UDI
Identifiers
- Catalog Number
- GIN-DCA026 FDA UDI
- Primary DI / UDI-DI
- 07540194007353 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194FD-DRQN EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L1508 REAMERS, REUSABLE EUDAMED
- GMDN Term
- Fluted surgical drill bit, 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
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
Dimensions & Sizes
- Size
- Length — 330 Millimeter FDA UDIOuter Diameter — 2.7 Millimeter FDA UDI
Fassier-Duval Telescopic Im System by Orthopediatrics Canada ULC — Class I — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 ff6f2098-85d5-40fc-a7f9-0c4a22110c3b 37 fields · synced Oct 7, 2026
- EUDAMED e619a3b1-8ee3-41ea-85f0-f4719645ad79 61 fields · synced Jul 28, 2026