Identity
- Trade Name
- PRESSE A COTYLE ESIC MODELE DEPOSE EUDAMEDOURY-GUYE & FILS FDA UDI
- Generic Name
- Orthopaedic implant/instrument assembling device FDA UDI
- Device Name
- Orthopaedic implant preparation instruments EUDAMEDESIC® PRESS FDA UDI
- Model / Reference
- D11412M EUDAMEDA FDA UDI
- Description
- ESIC® PRESS FDA UDI
Identifiers
- Catalog Number
- D11412M FDA UDI
- Primary DI / UDI-DI
- 03665624019219 EUDAMEDFDA UDI
- Basic UDI-DI
- 03665624INST02J6 EUDAMED
- Direct Marketing DI
- 03665624019219 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic implant/instrument assembling device 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
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: Orthopaedic implant impactor, reusable
Presse A Cotyle Esic Modele Depose 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
CE/MDR
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 ab4c96d9-adf8-4c86-8c03-c0b7f45a80ae 61 fields · synced Jul 9, 2026
- FDA UDI d6ca3ddb-9fc3-4ad8-81c9-0c4de23741f3 35 fields · synced May 30, 2026