| Primary Device ID | 10846835017885 |
| NIH Device Record Key | c26526db-d426-4e7f-9062-600f60bae117 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VISITAG SURPOINT External Processing Unit |
| Version Model Number | D160801 |
| Catalog Number | D160801 |
| Company DUNS | 020163218 |
| Company Name | Biosense Webster Inc |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 10846835017885 [Primary] |
| OAD | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-02-10 |
| Device Publish Date | 2018-07-18 |
| 10846835010121 - Sterile Interface Cable | 2024-12-19 Cath to Generator CBL Sterile |
| 10846835025248 - TRUPULSE™ Generator | 2024-12-19 TRUPULSE Generator |
| 10846835025460 - VARIPULSE™ Bi-Directional Catheter | 2024-12-19 8.5 FR VARIPULSE™ Bi-Directional Catheter |
| 10846835022780 - SOUNDSTAR CRYSTAL Ultrasound Catheter | 2024-07-04 SOUNDSTAR CRYSTAL Ultrasound Catheter |
| 10846835016796 - TX eco EXT Cable | 2023-10-12 TX eco EXT Cable |
| 10846835025811 - OPTRELL Mapping Catheter with TRUEref Technology | 2023-10-12 OPTRELL-36 F-J Curve |
| 10846835025828 - OPTRELL Mapping Catheter with TRUEref Technology | 2023-10-12 OPTRELL-36 D-F Curve |
| 10846835017427 - TX eco Cable | 2023-07-31 TX eco Cable Kit |