| Primary Device ID | 10840763100107 |
| NIH Device Record Key | 8de511c9-850d-4c2a-9332-78cc18f0493c |
| Commercial Distribution Discontinuation | 2016-12-12 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Cellfina System Procedure Kit (Single Package) |
| Version Model Number | CK1-1 Rev. A |
| Company DUNS | 010981554 |
| Company Name | Ulthera, Inc. |
| Device Count | 5 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 | 00840763100100 [Unit of Use] |
| GS1 | 10840763100107 [Primary] |
| OUP | Powered Surgical Instrument For Improvement In The Appearance Of Cellulite |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-05-09 |
| Device Publish Date | 2016-12-12 |
| 00840763101169 - Ulthera System Cart | 2024-05-29 |
| 10840763100107 - Cellfina System Procedure Kit (Single Package) | 2024-05-09 |
| 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 |
| 00840763100414 - Cellfina System Disposable Tray | 2019-07-26 |
| 00840763100520 - Cellfina System Disposable Tray | 2019-07-26 |