| Primary Device ID | 07908611211590 |
| NIH Device Record Key | ac44320a-62cc-4723-be12-5888b72b52f0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORTHODONTIC ELASTIC - INTRAORAL - BLACK LATEX - MEDIUM 3/8 - 1000UN |
| Version Model Number | 60.01.2305 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |