| Primary Device ID | 06430035872480 |
| NIH Device Record Key | 9b7b9ebd-62cc-4288-8168-268c7aec319b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DIGORA Optime |
| Version Model Number | DXR60 |
| Catalog Number | 900682 |
| Company DUNS | 459955188 |
| Company Name | PaloDEx Group Oy |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| 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 |