| Primary Device ID | 00852184003298 |
| NIH Device Record Key | ee936382-3154-4c45-a09e-857a1127b3f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | System Destination Kit, SCI HDE, US |
| Version Model Number | 20-0061 |
| Company DUNS | 138432070 |
| Company Name | Synapse 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 |