| Primary Device ID | 00853730006046 |
| NIH Device Record Key | c440a486-2b9f-4e04-9bb6-7cc1e8809e7a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FlexiCoil™ |
| Version Model Number | FC-0.6-2-10-GG-20-20 |
| 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 |