Identity
- Trade Name
- TAPIS SILICONE GRAND EUDAMEDsilicone mat FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- TRAYS, LIDS, MATS EUDAMED
- Model / Reference
- 268728 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661489687280 EUDAMEDFDA UDI
- Basic UDI-DI
- 3661489PANIERCIAH EUDAMED
- 510(k) Number
- K162068 FDA UDI
- FDA Product Code
- KWT FDA UDIKWS FDA UDIMBF FDA UDI
- EMDN Code
- V0499 CLINICAL USE CONTAINERS (NON-IVD) - OTHER EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3650 FDA UDI888.3660 FDA UDI888.3670 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
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
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Instrument transport trolley system
Tapis Silicone Grand by Fournitures Hospitalieres Industrie — 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 | 3661489PANIERCIAH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fournitures Hospitalieres Industrie
- EUDAMED SRN
- FR-MF-000000819
Sources (2)
- EUDAMED f1d3ef5b-4b54-4309-b26a-38728911a058 61 fields · synced Jun 19, 2026
- FDA UDI 2d08b1fb-202b-4ad4-b04d-0934b6a33e63 33 fields · synced May 30, 2026