| Primary Device ID | 07908611210562 |
| NIH Device Record Key | 05164390-30b9-442f-89bd-107a74651ecf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ELASTOMERIC CHAIN ORTHOMETRIC - 1,5M - MEDIUM - MARSALA |
| Version Model Number | 60.05.6058 |
| 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |