| Primary Device ID | 06948806313914 |
| NIH Device Record Key | 3f6f3bd0-8a1d-4f2b-b8a8-afdfaf8947fd |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | C2500-10 |
| Company DUNS | 421256891 |
| Company Name | Synaptic Medical, Ltd. |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06948806313914 [Primary] |
| IKD | Cable, Electrode |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-14 |
| Device Publish Date | 2020-09-04 |
| 06948806322107 - NA | 2024-12-16 Steerable Intracardiac Catheter Introducer Kit |
| 06948806313914 - NA | 2020-09-14Cable, Electrode |
| 06948806313914 - NA | 2020-09-14 Cable, Electrode |
| 06948806313921 - NA | 2020-09-14 Cable, Electrode |
| 06948806313938 - NA | 2020-09-14 Cable, Electrode |
| 06948806353019 - NA | 2019-06-07 Intracardiac Catheter Introducer Kit |
| 06948806353026 - NA | 2019-06-07 Intracardiac Catheter Introducer Kit |
| 06948806353033 - NA | 2019-06-07 Intracardiac Catheter Introducer Kit |
| 06948806353040 - NA | 2019-06-07 Intracardiac Catheter Introducer Kit |