| Primary Device ID | 06948806311026 |
| NIH Device Record Key | 380e9554-ebc8-4fd1-8d75-23d8e8674818 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | F6004005115FRT |
| Catalog Number | F6004005115FRT |
| Company DUNS | 421256891 |
| Company Name | Synaptic Medical, Ltd. |
| 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 | 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +861051297209 |
| service@synapticmed.com.cn |
| Catheter Gauge | 6 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06948806311026 [Primary] |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-11-15 |
| 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 |
| 06948806353057 - NA | 2019-06-07 Intracardiac Catheter Introducer Kit |