| Primary Device ID | 00889024671102 |
| NIH Device Record Key | 8fa83820-9471-4294-93f5-39c1a2293fc4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PLANNING STATION - ROSA ONE - USA |
| Version Model Number | 164017-02 |
| Company DUNS | 264502977 |
| Company Name | MEDTECH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |