| Primary Device ID | 03661690000083 |
| NIH Device Record Key | 90bcccfe-f347-4ed5-90cb-8837ac59c96e |
| Commercial Distribution Discontinuation | 2020-06-03 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Sonolith Carbon Fiber Table |
| Version Model Number | TMS 230811 |
| Catalog Number | TMS230811 |
| Company DUNS | 383113362 |
| Company Name | EDAP-TMS FRANCE |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 512 832-7956 |
| mhull@edap-usa.com | |
| Phone | 512 832-7956 |
| mhull@edap-usa.com | |
| Phone | 512 832-7956 |
| mhull@edap-usa.com | |
| Phone | 512 832-7956 |
| mhull@edap-usa.com | |
| Phone | 512 832-7956 |
| mhull@edap-usa.com | |
| Phone | 512 832-7956 |
| mhull@edap-usa.com | |
| Phone | 512 832-7956 |
| mhull@edap-usa.com | |
| Phone | 512 832-7956 |
| mhull@edap-usa.com | |
| Phone | 512 832-7956 |
| mhull@edap-usa.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03661690000083 [Primary] |
| MMZ | Table, Cystometric, Electric |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2024-12-11 |
| Device Publish Date | 2016-09-21 |
| 03661690000014 - Ablapak | 2024-12-11 The Ablapak is he single use kit of consumables to support a single patient procedure using the Ablatherm Integrated Imaging sys |
| 03661690000076 - Ablatherm Endorectal Probe | 2024-12-11 The Ablatherm Endorectal Probe is a primary component of the Ablatherm Integrated Imaging system which is a computer-controlled |
| 03661690000083 - Sonolith Carbon Fiber Table | 2024-12-11One piece carbon fiber table for use with SONOLITH® i-move or i-sys lithotripsy devices for ESWL(Extracorporeal Shock Wave Lithotnpsy). |
| 03661690000083 - Sonolith Carbon Fiber Table | 2024-12-11 One piece carbon fiber table for use with SONOLITH® i-move or i-sys lithotripsy devices for ESWL(Extracorporeal Shock Wave Lith |
| 03661690000090 - Endo-i-move Table | 2024-12-11 A table for use with the SONOLITH® i-move medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy) |
| 03661690000106 - Sonolith i-move Standard Module | 2024-12-11 SONOLITH® i-move medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). The physical principle |
| 03661690000113 - Sonolith i-move Visio-Track Module | 2024-12-11 SONOLITH® i-move Visio-Track medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). The physica |
| 03661690000120 - Sonolith i-move Touch Module | 2024-12-11 SONOLITH® i-move Touch medical device is a lithotripter of ESWL type (Extracorporeal Shock Wave Lithotripsy). The physical prin |
| 03661690000144 - Ablatherm Integrated Imaging | 2024-12-11 The device is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HI |