| Primary Device ID | 00852184003069 |
| NIH Device Record Key | 9408b9db-01cf-42c5-8f6c-8ee0571555b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | System Destination Kit, CE 2 EPG |
| Version Model Number | 20-0063 |
| 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 |