Identity
- Trade Name
- FRENCH BENDER EUDAMEDOURY-GUYE & FILS FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Orthopaedic implant preparation instruments EUDAMEDFRENCH BENDER 28 CM FDA UDI
- Model / Reference
- D11079M EUDAMEDA FDA UDI
- Description
- FRENCH BENDER 28 CM FDA UDI
Identifiers
- Catalog Number
- D11079M FDA UDI
- Primary DI / UDI-DI
- 03665624021229 EUDAMEDFDA UDI
- Basic UDI-DI
- 03665624INST02J6 EUDAMED
- Direct Marketing DI
- 03665624021229 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091002 INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- France 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
Category: Wire holding/twisting forceps
French Bender by Etablissements Oury Guye Et Fils — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 03665624INST02J6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Etablissements OURY-GUYE et Fils
- EUDAMED SRN
- FR-MF-000020162
Sources (2)
- EUDAMED f483a3c2-5566-4d9a-a8df-a660d0f77726 61 fields · synced Jul 27, 2026
- FDA UDI e85b1397-8ba4-4cb4-a54e-375c852ae95b 35 fields · synced May 30, 2026