| Primary Device ID | 07908611211323 | 
| NIH Device Record Key | 63630b30-c1e0-4d9f-b351-c1e8972fa92d | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | EXTRA-ORAL ELASTIC 16 OZ 1/2" NO MINT FLAVOR | 
| Version Model Number | 60.01.3203 | 
| 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 |