| Primary Device ID | 05415067034960 |
| NIH Device Record Key | 70178e01-06b7-47d1-9b0e-a3895e653864 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 55600 |
| Catalog Number | 55600 |
| 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 | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067034960 [Primary] |
| LGW | Stimulator, spinal-cord, totally implanted for pain relief |
| MHY | Stimulator, electrical, implanted, for parkinsonian tremor |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-01-12 |
| Device Publish Date | 2023-01-04 |
| 05415067047700 - TriClip™ | 2024-04-22 G4 Delivery System |
| 05415067047724 - TriClip™ | 2024-04-22 G4 Delivery System |
| 05415067047731 - TriClip™ | 2024-04-22 G4 Delivery System |
| 05415067047748 - TriClip™ | 2024-04-22 Steerable Guide Catheter |
| 05415067047755 - TriClip™ | 2024-04-22 G4 Delivery System |
| 05415067050014 - EnSite™ | 2024-04-04 X EP System Software Upgrade |
| 05415067050021 - EnSite™ | 2024-04-04 X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade |
| 05415067050281 - EnSite™ | 2024-04-04 X EP System PFA Catheter Visualization Temporary Software License |