| Primary Device ID | 00810106971445 |
| NIH Device Record Key | 52713ac7-f721-463a-8d09-a27fcfa85c2d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vivos DNA |
| Version Model Number | 5.014 |
| Company DUNS | 243286441 |
| Company Name | Aurum Group Ltd |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810106971445 [Primary] |
| LRK | Device, Anti-Snoring |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-03 |
| Device Publish Date | 2023-09-25 |
| 00810106971438 - Vivos mRNA | 2023-10-03 An intraoral device for the treatment of snoring and mild to moderate obstructive sleep apnea in adults. |
| 00810106971445 - Vivos DNA | 2023-10-03The Vivos appliance is an adult palate expander used to treat adults who clench their teeth, have TMJ pain, and sleep apnea. |
| 00810106971445 - Vivos DNA | 2023-10-03 The Vivos appliance is an adult palate expander used to treat adults who clench their teeth, have TMJ pain, and sleep apnea. |
| 00810106971452 - Vivos mmRNA | 2023-09-29 The mmRNA appliance is an intraoral device used for treating snoring and mild to moderate snoring and mild to moderate sleep apn |