| Primary Device ID | 08800118607175 |
| NIH Device Record Key | 9ba8a9c9-85ac-40cd-ad2d-13f38a8f60f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Chang's Iris |
| Version Model Number | Iris F1 12T |
| Company DUNS | 694821663 |
| Company Name | U&C International 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 | 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 | true |
| OTC Over-The-Counter | false |