| Primary Device ID | 00853730006251 |
| NIH Device Record Key | 7e2903b6-3bcd-4d91-a641-dc2ac873e9b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FusionCoil™ |
| Version Model Number | FC-1.0-20-18-5 |
| Company DUNS | 832596816 |
| Company Name | CORTEX MANUFACTURING INC. |
| 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 | false |
| OTC Over-The-Counter | false |