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The Fassier-Duval Telescopic IM System
EUDAMEDFDA UDIClass I (EU MDR)
Ref FC-BURRModel BURR
Identity
- Trade Name
- The Fassier-Duval Telescopic IM System EUDAMEDFASSIER-DUVAL TELESCOPIC IM SYSTEM FDA UDI
- Generic Name
- Metal-cutting bur FDA UDI
- Device Name
- TAPERED BURR FDA UDI
- Model / Reference
- BURR EUDAMEDFC-BURR EUDAMEDFDA UDI
- Description
- TAPERED BURR FDA UDI
Identifiers
- Catalog Number
- FC-BURR FDA UDI
- Primary DI / UDI-DI
- 07540194006721 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194FD-BURRK7 EUDAMED
- FDA Product Code
- HTT FDA UDI
- EMDN Code
- L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Metal-cutting bur 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
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
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-BURRK7 | 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 b8df17ea-5c0b-48dc-8785-6a2ea9a50f03 61 fields · synced Jul 15, 2026
- FDA UDI fff75755-4003-4f58-a810-d184ddeac556 36 fields · synced May 30, 2026