| Primary Device ID | 07640157990217 |
| NIH Device Record Key | 6d3b70be-03ef-4d9d-9afe-a124962ff0f8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TactiSys™ |
| Version Model Number | Quartz |
| Catalog Number | PN-001427 |
| 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 |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640157990217 [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 | 3 |
| Public Version Date | 2019-07-01 |
| Device Publish Date | 2014-11-03 |
| 07640157990316 | Quartz |
| 07640157990217 | Quartz |
| 07640157990194 | Equipment |
| 07640157990187 | Quartz |
| 07640157990064 | Quartz |
| 07640157990057 | Quartz |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TACTISYS 85080190 3900774 Live/Registered |
ENDOSENSE SA 2010-07-08 |