| Primary Device ID | 05415067029805 |
| NIH Device Record Key | f4da9a88-89c3-403b-bd91-5bef9edeb112 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 905-15 |
| Catalog Number | 905-15 |
| Company DUNS | 149818952 |
| Company Name | ST. JUDE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067029805 [Primary] |
| DTI | SIZER, HEART-VALVE, PROSTHESIS |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[05415067029805]
Moist Heat or Steam Sterilization
[05415067029805]
Moist Heat or Steam Sterilization
[05415067029805]
Moist Heat or Steam Sterilization
[05415067029805]
Moist Heat or Steam Sterilization
[05415067029805]
Moist Heat or Steam Sterilization
[05415067029805]
Moist Heat or Steam Sterilization
[05415067029805]
Moist Heat or Steam Sterilization
[05415067029805]
Moist Heat or Steam Sterilization
[05415067029805]
Moist Heat or Steam Sterilization
[05415067029805]
Moist Heat or Steam Sterilization
[05415067029805]
Moist Heat or Steam Sterilization
[05415067029805]
Moist Heat or Steam Sterilization
[05415067029805]
Moist Heat or Steam Sterilization
[05415067029805]
Moist Heat or Steam Sterilization
[05415067029805]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-11 |
| Device Publish Date | 2019-02-11 |
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| 05415067049421 - Gallant™ | 2024-05-03 VR Implantable Cardioverter Defibrillator |
| 05415067049469 - Entrant™ | 2024-05-03 DR Implantable Cardioverter Defibrillator |
| 05415067049476 - Gallant™ | 2024-05-03 DR Implantable Cardioverter Defibrillator |
| 05415067049513 - Entrant™ | 2024-05-03 HF Cardiac Resynchronization Therapy Defibrillator |
| 05415067049520 - Gallant™ | 2024-05-03 HF Cardiac Resynchronization Therapy Defibrillator |
| 05415067047700 - TriClip™ | 2024-04-22 G4 Delivery System |
| 05415067047724 - TriClip™ | 2024-04-22 G4 Delivery System |