| Primary Device ID | 08809455601051 |
| NIH Device Record Key | 2d3c4a2b-20f4-4ab7-9d34-cadc2136f532 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | i-ROOT |
| Version Model Number | 404010 |
| Company DUNS | 687503532 |
| Company Name | META SYSTEMS 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 | false |
| Lot Batch | false |
| Serial Number | false |
| 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 |