Primary Device ID | 05415067031129 |
NIH Device Record Key | f09c176a-0dfe-4a8f-aaa7-8957fc8f72b7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Dragonfly OpStar™ |
Version Model Number | 1014651 |
Catalog Number | 1014651 |
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 | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
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 |
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 | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05415067031129 [Primary] |
DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-12-25 |
Device Publish Date | 2019-12-17 |
05414734403245 - N/A | 2025-06-19 4-Ch DBS Extension Kit, 50cm |
05414734403252 - N/A | 2025-06-19 4-Ch DBS Extension Kit, 60cm |
05414734405591 - Brio™ | 2025-06-19 LE Charging System |
05415067032027 - Tendyne™ | 2025-06-06 2 lb Weight |
05415067032096 - Tendyne™ | 2025-06-06 Stand |
05415067032447 - Tendyne™ | 2025-06-06 Mitral Valve |
05415067032454 - Tendyne™ | 2025-06-06 Mitral Valve |
05415067032461 - Tendyne™ | 2025-06-06 Mitral Valve |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() DRAGONFLY OPSTAR 87780582 not registered Live/Pending |
LightLab Imaging, Inc. 2018-02-01 |