| Primary Device ID | 00840763100049 |
| NIH Device Record Key | 60e07ae8-1d2b-4c1a-bea7-0ed5c572c122 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ulthera System Transducer |
| Version Model Number | UT-2 Rev. I |
| 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 | true |
| 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 | 00840763100049 [Primary] |
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-12-14 |
| 00840763100896 | UT-4N Rev L |
| 00840763100889 | UT-4 Rev L |
| 00840763100865 | UT-1 Rev N |
| 00840763100858 | UT-3 Rev N |
| 00840763100841 | UT-2 Rev O |
| 00840763100834 | UT-1N Rev N |
| 00840763100360 | UT-1N Rev. H |
| 00840763100353 | UT-3 Rev. H |
| 00840763100346 | UT-4 Rev. G |
| 00840763100339 | UT-2 Rev. J |
| 00840763100322 | UT-4N Rev. G |
| 00840763100315 | UT-1 Rev H |
| 00840763100070 | UT-4N Rev. F |
| 00840763100063 | UT-4 Rev. F |
| 00840763100056 | UT-3 Rev. G |
| 00840763100049 | UT-2 Rev. I |
| 00840763100032 | UT-1N Rev. G |