| Primary Device ID | 04260166371093 |
| NIH Device Record Key | adb5849f-6848-4b19-8fa4-93f213144eaf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmartAblateTM System Irrigation Pump |
| Version Model Number | M490008 |
| Company DUNS | 327536314 |
| Company Name | Stockert GmbH |
| 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 | false |
| Expiration Date | false |
| 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 | 04260166371093 [Primary] |
| LPB | Cardiac Ablation Percutaneous Catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2014-09-23 |
| 04260166371314 - SmartAblate Gen-Rem Cable | 2018-05-28 SmartAblate Connection Cable Generator - Remote (30 m) |
| 04260166371321 - SmartAblate Foot Pedal ext. Cable | 2018-05-28 SmartAblate Foot Pedal extension cable (7 m) |
| 04260166371345 - SMARTABLATE-SCom. Recording-/CARTO® Cable | 2018-05-28 SMARTABLATE Serial Data Com. Cable Recording-/CARTO® Systems 15 m |
| 04260166371352 - SMARTABLATE SCom. Recording-/CARTO® Cable | 2018-05-28 SMARTABLATE Serial Data Com. Cable Recording-/CARTO® Systems 3 m |
| 04260166370041 - GLOBAL PORT | 2018-05-10 |
| 04260166370195 - STOCKERT 70 | 2018-05-10 |
| 04260166370256 - STOCKERT REMOTE CONTROL | 2018-05-10 |
| 04260166370300 - STOCKERT EP/IO Interface Box | 2018-05-10 |