| Primary Device ID | 00883205015600 |
| NIH Device Record Key | b067410d-7292-4f5b-bd4a-8bb874c4f7da |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Opal Band |
| Version Model Number | 500086 |
| Catalog Number | 500086 |
| Company DUNS | 013369913 |
| Company Name | ULTRADENT PRODUCTS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 |