Primary Device ID | 05415067032027 |
NIH Device Record Key | 5c7f1aff-9e26-4cec-8bb9-496707260592 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Tendyne™ |
Version Model Number | TENDV-WT |
Catalog Number | TENDV-WT |
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 | |
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 |
Weight | 2 Pound |
Weight | 2 Pound |
Weight | 2 Pound |
Weight | 2 Pound |
Weight | 2 Pound |
Weight | 2 Pound |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05415067032027 [Primary] |
NPU | Prosthesis, mitral valve, percutaneously delivered |
Steralize Prior To Use | true |
Device Is Sterile | false |
[05415067032027]
Moist Heat or Steam Sterilization
[05415067032027]
Moist Heat or Steam Sterilization
[05415067032027]
Moist Heat or Steam Sterilization
[05415067032027]
Moist Heat or Steam Sterilization
[05415067032027]
Moist Heat or Steam Sterilization
[05415067032027]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-06-06 |
Device Publish Date | 2025-05-29 |
05415067046192 | Retrieval System |
05415067032720 | Stand Components |
05415067032713 | Pad Positioning System |
05415067032706 | Loading System |
05415067032690 | Delivery System |
05415067032683 | Apical Pad - Large |
05415067032676 | Apical Pad - Small |
05415067032669 | Mitral Valve |
05415067032652 | Mitral Valve |
05415067032645 | Mitral Valve |
05415067032638 | Mitral Valve |
05415067032621 | Mitral Valve |
05415067032614 | Mitral Valve |
05415067032607 | Mitral Valve |
05415067032591 | Mitral Valve |
05415067032584 | Mitral Valve |
05415067032577 | Mitral Valve |
05415067032560 | Mitral Valve |
05415067032553 | Mitral Valve |
05415067032546 | Mitral Valve |
05415067032539 | Mitral Valve |
05415067032522 | Mitral Valve |
05415067032515 | Mitral Valve |
05415067032508 | Mitral Valve |
05415067032492 | Mitral Valve |
05415067032485 | Mitral Valve |
05415067032478 | Mitral Valve |
05415067032461 | Mitral Valve |
05415067032454 | Mitral Valve |
05415067032447 | Mitral Valve |
05415067032096 | Stand |
05415067032027 | 2 lb Weight |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() TENDYNE 86609447 not registered Live/Pending |
Tendyne Holdings, Inc. 2015-04-24 |
![]() TENDYNE 85669495 not registered Dead/Abandoned |
Tendyne Holdings, Inc. 2012-07-05 |