| Primary Device ID | 08800046040419 |
| NIH Device Record Key | e06de766-28a9-407e-a681-79d96def2ee5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ASS413-2U |
| Version Model Number | ASS413-2U |
| Company DUNS | 694828541 |
| Company Name | GNI 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |