The Fassier-Duval Telescopic IM System
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- The Fassier-Duval Telescopic IM System EUDAMEDFASSIER-DUVAL TELESCOPIC IM SYSTEM FDA UDI
- Generic Name
- Orthopaedic implantable-device cutter FDA UDI
- Device Name
- MALE CUTTER - 5 HOLES FDA UDI
- Model / Reference
- MALE CUTTER - 5 HOLES EUDAMEDMC100 EUDAMEDFDA UDI
- Description
- MALE CUTTER - 5 HOLES FDA UDI
Identifiers
- Catalog Number
- MC100 FDA UDI
- Primary DI / UDI-DI
- 07540194006868 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194FD-MC1JF EUDAMED
- FDA Product Code
- HXZ FDA UDI
- EMDN Code
- L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic implantable-device cutter 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Bone cutting forceps, reusable
The Fassier-Duval Telescopic IM System by Orthopediatrics Canada Ulc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7540194FD-MC1JF | 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 213ad44c-084f-4fdf-9c37-5c203f06495a 61 fields · synced Jul 29, 2026
- FDA UDI 90df99c2-8f5d-4e0f-bc78-cc7eed11de65 36 fields · synced May 30, 2026