| Primary Device ID | B447RM4405210 |
| NIH Device Record Key | 12114aed-bdb7-4754-8c6c-339b4df27659 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mixing and Delivery System |
| Version Model Number | Cannula Pak |
| Catalog Number | RM 44-052 |
| Company DUNS | 003506272 |
| Company Name | BONE SOLUTIONS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B447RM4405210 [Primary] |
| FMF | Syringe, Piston |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-07 |
| Device Publish Date | 2020-07-30 |
| B4474400000AUX0 | The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, au |
| B447RM4405210 | The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, au |
| B447RM4405110 | The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, au |
| B447RM4405010 | The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, au |
| B4477120010 | The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, au |