| Primary Device ID | 07613353000011 |
| NIH Device Record Key | 8a4a0135-ee3a-4ac6-9b35-e5da0ede1fc6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Swiss DolorClast |
| Version Model Number | FT-183 |
| Company DUNS | 481233849 |
| Company Name | E.M.S. Electro Medical Systems S.A. |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +41229944700 |
| welcome@ems-ch.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613353000011 [Primary] |
| NBN | Generator, Shock-Wave, For Pain Relief |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2018-09-24 |
| Device Publish Date | 2015-11-04 |
| 07613353077464 | Swiss DolorClast |
| 07613353000066 | Gel bottle |
| 07613353000059 | Pneumatic foot pedal |
| 07613353000042 | Applicator Ø15mm |
| 07613353000035 | Handpiece DolorClast |
| 07613353000028 | Handpiece kit DolorClast |
| 07613353000011 | Swiss DolorClast |
| 07613353181284 | Handpiece DolorClast |
| 07613353170264 | Gel bottle |
| 07613353194895 | Cart StackUp |
| 04260153472031 | Gel bottle |
| 07613353226053 | DolorClast Radial |
| 07613353187101 | Compact Cart DolorClast |