| Primary Device ID | D785325SB0 |
| NIH Device Record Key | 25d04246-086f-483c-a14a-d5a1ad78f835 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SCAN BODY |
| Version Model Number | TSI/ERI 3.25MM SCAN BODY |
| Catalog Number | 3.25 SB |
| Company DUNS | 094146123 |
| Company Name | OCO BIOMEDICAL INC |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |