| Primary Device ID | 00815212022449 |
| NIH Device Record Key | 1fb6cfb0-f125-408c-ad06-65b132dbbba9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Thermoplastic Mask |
| Version Model Number | MK8028 |
| Company DUNS | 933506164 |
| Company Name | Izi Medical Products, LLC |
| 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 | false |
| 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 |