| Primary Device ID | 07290018152027 |
| NIH Device Record Key | 315cc7f4-7021-4f4c-a85a-5a820dd8a2dd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sofwave Applicator |
| Version Model Number | FG00002-R |
| Catalog Number | FG00002-R |
| Company DUNS | 531962539 |
| Company Name | SOFWAVE MEDICAL LTD |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290018152027 [Primary] |
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-04 |
| Device Publish Date | 2021-05-27 |
| 07290018152010 | FG00002 |
| 07290018152027 | FG00002-R |
| 07290018152065 | This applicator is the refurbish version of the small (precise) applicator, designed to allow th |
| 07290018152058 | The SofWave System is an ultrasound system intended for aesthetic purposes. The SofWave System c |
| 07290018152089 | The SofWave System is an ultrasound system intended for aesthetic purposes. The SofWave System c |