| 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 | 
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