| Primary Device ID | 00812593021634 |
| NIH Device Record Key | 3fa1ddb2-b4f2-4dca-8715-4ef43bf2daa8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ossFX Moldable |
| Version Model Number | AXB-OSS-03 |
| Company DUNS | 832270370 |
| Company Name | Biogennix, 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |