Identity
- Trade Name
- Carbon Fiber Table W2E FDA UDI
- Generic Name
- Electromechanical lithotripsy system, extracorporeal FDA UDI
- Device Name
- A carbon fiber table with removable right and left panels for use with the SONOLITH® i-move medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). FDA UDI
- Model / Reference
- TMS 234181 FDA UDI
- Description
- A carbon fiber table with removable right and left panels for use with the SONOLITH® i-move medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). FDA UDI
Identifiers
- Catalog Number
- TMS 234181 FDA UDI
- Primary DI / UDI-DI
- 03661690000151 FDA UDI
- 510(k) Number
- K111808 FDA UDI
- FDA Product Code
- MMZ FDA UDI
- GMDN Term
- Electromechanical lithotripsy system, extracorporeal FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4890 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Carbon Fiber Table W2E by Edap-Tms France — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Edap-Tms France
Sources (1)
- FDA UDI b17f6603-fa0e-4898-970f-d8fe7fcc8ef4 37 fields · synced Jun 1, 2026