| Primary Device ID | 00883205101648 |
| NIH Device Record Key | 6389de13-2c13-4a86-9d4f-8b72c4a080e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Genius Variable Operating System |
| Version Model Number | 4056 |
| Catalog Number | 4056 |
| Company DUNS | 013369913 |
| Company Name | ULTRADENT PRODUCTS, 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(801)572-4200 |
| customerservice@ultradent.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00883205101648 [Primary] |
| EBW | Controller, foot, handpiece and cord |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00883205101648]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-02-07 |
| 00883205031778 - Ultrapak | 2024-04-03 Sample Cord Ultradent |
| 00883205034168 - VALO | 2024-03-04 VALO X ProxiCure Ball Lens 2pk |
| 00883205034175 - VALO | 2024-03-04 VALO X PointCure Lens 2pk |
| 00883205034182 - VALO | 2024-03-04 VALO X TransLume Lens 2pk |
| 00883205034199 - VALO | 2024-03-04 VALO X Interproximal Lens 2pk |
| 00883205034205 - VALO | 2024-03-04 VALO X Diffuser Lens 1pk |
| 00883205027948 - PermaShade Try-In Paste | 2024-01-19 PermaShade Try-In Paste Kit |
| 00883205027955 - PermaShade Try-In Paste | 2024-01-19 PermaShade Try-In Paste Translucent Refill |