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
- CUTTER TUBE ASSEMBLY Ø6.4mm FDA UDI
- Model / Reference
- CUTTER TUBE ASSEMBLY EUDAMEDMC200-TUBE 64 EUDAMEDFDA UDI
- Description
- CUTTER TUBE ASSEMBLY Ø6.4mm FDA UDI
Identifiers
- Catalog Number
- MC200-TUBE 64 FDA UDI
- Primary DI / UDI-DI
- 07540194006936 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194FD-CTBKG 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
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 3.95 Millimeter FDA UDI
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
Similar devices
Also classified as Bone cutting forceps, reusable.
- Acetabular Reamer 47mm — Viant Medical, LLC · Class IIa
- Gimmi — Gimmi GmbH · Class I
- GLOBAL UNITE — DePuy Ireland UC · Class I
- KNEO FEMORAL CUTTING BLOCK S08 — groupe lépine · Class I
- AG15-0002 — X.NOV MEDICAL TECHNOLOGY · Class I
- SPECIALIST 2 — DePuy Ireland UC · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- Acetabular Reamer 55mm — Viant Medical, LLC · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7540194FD-CTBKG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OrthoPediatrics Canada ULC
- EUDAMED SRN
- CA-MF-000013010
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 7a7e856b-e19f-4bc4-921b-0dea6e327cfb 61 fields · synced Jul 12, 2026
- FDA UDI 0c4becd4-cd99-46cf-a090-5f105895df59 37 fields · synced May 30, 2026