| Primary Device ID | B502BSB68850 | 
| NIH Device Record Key | 238c029b-6eb3-47b8-8d5d-5ed460451417 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Tinto MCM3 RMab | 
| Version Model Number | Predilute, 7 ml | 
| Catalog Number | BSB 6885 | 
| Company DUNS | 102855447 | 
| Company Name | BIO SB, INC. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | MR Safe | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | false | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false |