| Primary Device ID | 00850012226291 |
| NIH Device Record Key | 049b463b-6bc6-4150-9e35-c238069db322 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iMap 3D Mapping and Navigation System |
| Version Model Number | 820000 |
| Company DUNS | 117364041 |
| Company Name | Cardionxt 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |