| Primary Device ID | 08800038044944 |
| NIH Device Record Key | 1c8c8514-00c8-4450-852e-32713a81dcd3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MEDINAUT Flex |
| Version Model Number | MDF1 |
| Company DUNS | 690340653 |
| Company Name | IMEDICOM CO., LTD. |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800038044944 [Primary] |
| OCJ | Spinal Channeling Instrument, Vertebroplasty |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-26 |
| Device Publish Date | 2020-10-16 |
| 08800038060265 - EZX | 2025-07-25 EZX (EZX Tray) |
| 08800038060272 - EZX | 2025-07-25 EZX (Tray Cover) |
| 08800038060289 - EZX | 2025-07-25 EZX (Lower Tray) |
| 08800038060296 - EZX | 2025-07-25 EZX (Upper Tray) |
| 08800038060302 - EZX | 2025-07-25 EZX(Main Tray) |
| 08800038060142 - MEDINAUT-Ix | 2025-07-23 Cannula(132mm) and Trocar type Needle |
| 08800038060159 - MEDINAUT-Ix | 2025-07-23 Cannula(132mm) and Bevel type Needle |
| 08800038060166 - MEDINAUT-Ix | 2025-07-23 Cannula(132mm) and Diamond type Needle |