| Primary Device ID | 07908611214966 |
| NIH Device Record Key | 3413722d-94d7-49fc-a971-33d6b68ca9d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CLASS II CORRECTOR - ICERAM CLEAR DISTALIZER - 16MM - 2UN |
| Version Model Number | 11.90.1012 |
| Company DUNS | 898330003 |
| Company Name | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |