| Primary Device ID | 08800038060210 |
| NIH Device Record Key | f0df120d-91b6-4c3e-b7be-46bc7aa1795b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MEDINAUT-Ix |
| Version Model Number | ICD-CA3 / MIX-EX3B |
| 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 | 08800038060210 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-23 |
| Device Publish Date | 2025-07-15 |
| 08800038060258 | Cannula(155.5mm) and Diamond type Needle |
| 08800038060241 | Cannula(155.5mm) and Bevel type Needle |
| 08800038060234 | Cannula(155.5mm) and Trocar type Needle |
| 08800038060227 | Cannula(160mm) and Diamond type Needle |
| 08800038060210 | Cannula(160mm) and Bevel type Needle |
| 08800038060203 | Cannula(160mm) and Trocar type Needle |
| 08800038060197 | Cannula(150mm) and Diamond type Needle |
| 08800038060180 | Cannula(150mm) and Bevel type Needle |
| 08800038060173 | Cannula(150mm) and Trocar type Needle |
| 08800038060166 | Cannula(132mm) and Diamond type Needle |
| 08800038060159 | Cannula(132mm) and Bevel type Needle |
| 08800038060142 | Cannula(132mm) and Trocar type Needle |