| Primary Device ID | 08809278790048 |
| NIH Device Record Key | cefbed90-04c1-43ab-8fc1-c2cd95e85a3a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reformat Gateway |
| Version Model Number | Reformat Gateway |
| Company DUNS | 688319156 |
| Company Name | INFINITT Healthcare 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 | true |
| 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 |