| Primary Device ID | 00840763100438 |
| NIH Device Record Key | 07d1d614-afeb-4887-a68b-16328e86b94d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ulthera System Handpiece |
| Version Model Number | UH-2 Rev. H |
| 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 | 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 | 00840763100438 [Primary] |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic |
| 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 |
| 00840763100919 | UH-2 Rev N |
| 00840763100506 | UH-2 Rev. J |
| 00840763100490 | UH-2 Rev. I |
| 00840763100483 | UH-2 Rev. 1 |
| 00840763100438 | UH-2 Rev. H |
| 00840763100421 | UH-2 Rev. G |
| 00840763100308 | UH-2 Rev. F |
| 00840763100292 | UH-2 Rev. E |
| 00840763100285 | UH-2 Rev. D |
| 00840763100278 | UH-2 Rev. C |
| 00840763100261 | UH-2 Rev. B |
| 00840763100018 | UH-2 Rev. A |
| 00840763101152 | UH-2 DS 2.0 Rev A |