| Primary Device ID | 00812593021566 |
| NIH Device Record Key | f205722b-0f16-43b7-af2d-52343bc83989 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DirectCell Autograft and Marrow Harvesting System |
| Version Model Number | AMS-MC-RAN-8C |
| Catalog Number | AMS-MC-RAN-8C |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |