| Primary Device ID | 00840763100025 |
| NIH Device Record Key | 29f3a029-c884-4aa3-b1ea-043e048bf002 |
| Commercial Distribution Discontinuation | 2019-07-18 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Ulthera System Transducer DS 7-3.0 |
| Version Model Number | UT-1 Rev G |
| Company DUNS | 010981554 |
| Company Name | ULTHERA, INC. |
| 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 | true |
| 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 | 00840763100025 [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 | 2019-07-26 |
| Device Publish Date | 2019-07-18 |
| 00840763101169 - Ulthera System Cart | 2024-05-29 |
| 10840763100107 - Cellfina System Procedure Kit (Single Package) | 2024-05-09 |
| 00840763101145 - Ulthera System Control Unit PRIME | 2024-04-18 |
| 00840763101152 - Ulthera System Handpiece | 2024-04-16 |
| 00840763100742 - Cellfina Motor Module Device and Package | 2020-02-03 |
| 00840763100025 - Ulthera System Transducer DS 7-3.0 | 2019-07-26 |
| 00840763100025 - Ulthera System Transducer DS 7-3.0 | 2019-07-26 |
| 00840763100414 - Cellfina System Disposable Tray | 2019-07-26 |
| 00840763100520 - Cellfina System Disposable Tray | 2019-07-26 |