| Primary Device ID | M263G200600 |
| NIH Device Record Key | fb0aabec-ad92-47e4-ba56-a10cc90c6244 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GENIUS Blood and Marrow Concentration (BM/C) System |
| Version Model Number | 64150-04 |
| Catalog Number | G20060 |
| Company DUNS | 131107757 |
| Company Name | DSM BIOMEDICAL, 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 | true |
| OTC Over-The-Counter | false |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Total Volume | 60 Microliter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M263G200600 [Primary] |
| ORG | Platelet And Plasma Separator For Bone Graft Handling |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-09 |
| Device Publish Date | 2017-10-02 |
| M263G200600 | 60mL Disposable Kit |
| M263G2003009 | Disposable Unit |