| Primary Device ID | 06948806353118 | 
| NIH Device Record Key | 4d805662-dc80-4936-8161-edb76cbda955 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | N/A | 
| Version Model Number | S0856332L2 | 
| 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 | true | 
| 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 | 06948806353118 [Primary] | 
| DYB | Introducer, Catheter | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2019-06-07 | 
| 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 |