| Primary Device ID | 06948806311040 |
| NIH Device Record Key | 4b637877-9608-47e8-a274-154730ce61b9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | F4010282065PRT |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06948806311040 [Primary] |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-06-18 |
| Device Publish Date | 2018-05-17 |
| 06948806353194 | Intracardiac Catheter Introducer Kit |
| 06948806353187 | Intracardiac Catheter Introducer Kit |
| 06948806353170 | Intracardiac Catheter Introducer Kit |
| 06948806353163 | Intracardiac Catheter Introducer Kit |
| 06948806353156 | Intracardiac Catheter Introducer Kit |
| 06948806353149 | Intracardiac Catheter Introducer Kit |
| 06948806353132 | Intracardiac Catheter Introducer Kit |
| 06948806353125 | Intracardiac Catheter Introducer Kit |
| 06948806353118 | Intracardiac Catheter Introducer Kit |
| 06948806353101 | Intracardiac Catheter Introducer Kit |
| 06948806353095 | Intracardiac Catheter Introducer Kit |
| 06948806311040 | Electrophysiology Catheter |
| 06948806311033 | Electrophysiology Catheter |