| Primary Device ID | 05907642694565 |
| NIH Device Record Key | 32e8553b-a978-4618-8895-4afe1bbccdd1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Refraction Unit |
| Version Model Number | TRU-800 |
| Company DUNS | 366126408 |
| Company Name | MDT SP Z O O |
| 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 | 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 | false |
| OTC Over-The-Counter | false |