| Primary Device ID | 04719878713016 |
| NIH Device Record Key | f83a2eb1-bdde-4e3a-a4a4-72cd59940d2a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disposable Passive Sphere |
| Version Model Number | CDS-DPS-00 |
| Company DUNS | 658875222 |
| Company Name | Taiwan Main Orthopaedic Biotechnology Co., Ltd. |
| 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 | 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 |