| Primary Device ID | 05415067029355 |
| NIH Device Record Key | 06f6fa3e-02f8-4d62-b711-4fdfad3a7121 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TactiSys™ Quartz Equipment |
| Version Model Number | Mounting Bracket |
| Catalog Number | TSM-ABV-GBL |
| Company DUNS | 149818952 |
| Company Name | ST. JUDE MEDICAL, 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 | true |
| 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 |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067029355 [Primary] |
| OAE | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
| 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 | 2017-10-12 |
| 05415067029355 | Tactisys to Precision Above Mounting Bracket |
| 05415067029348 | Tactisys to Precision Beside Mounting Bracket |
| 05415067034700 | TactiFlex Radiofrequency Cable |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TACTISYS 85080190 3900774 Live/Registered |
ENDOSENSE SA 2010-07-08 |