| Primary Device ID | 00852184003502 |
| NIH Device Record Key | 513b859e-a8bb-43a4-8110-d25ec4029ced |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | External Pulse Generator |
| Version Model Number | 23-0001 |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |