| Primary Device ID | 00857676008560 |
| NIH Device Record Key | 90a4f4d3-882c-4a70-aeef-7551eb6bd903 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iFUSE INTRA X Assist |
| Version Model Number | 973-002 |
| Catalog Number | 501986 |
| Company DUNS | 084330422 |
| Company Name | Eca Medical Instruments |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |