Tendyne™ TENDV-WT

GUDID 05415067032027

2 lb Weight

ST. JUDE MEDICAL, INC.

Pressure monitor calibration weight
Primary Device ID05415067032027
NIH Device Record Key5c7f1aff-9e26-4cec-8bb9-496707260592
Commercial Distribution StatusIn Commercial Distribution
Brand NameTendyne™
Version Model NumberTENDV-WT
Catalog NumberTENDV-WT
Company DUNS149818952
Company NameST. JUDE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Device Dimensions

Weight2 Pound
Weight2 Pound
Weight2 Pound
Weight2 Pound
Weight2 Pound
Weight2 Pound

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067032027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NPUProsthesis, mitral valve, percutaneously delivered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-06
Device Publish Date2025-05-29

On-Brand Devices [Tendyne™]

05415067046192Retrieval System
05415067032720Stand Components
05415067032713Pad Positioning System
05415067032706Loading System
05415067032690Delivery System
05415067032683Apical Pad - Large
05415067032676Apical Pad - Small
05415067032669Mitral Valve
05415067032652Mitral Valve
05415067032645Mitral Valve
05415067032638Mitral Valve
05415067032621Mitral Valve
05415067032614Mitral Valve
05415067032607Mitral Valve
05415067032591Mitral Valve
05415067032584Mitral Valve
05415067032577Mitral Valve
05415067032560Mitral Valve
05415067032553Mitral Valve
05415067032546Mitral Valve
05415067032539Mitral Valve
05415067032522Mitral Valve
05415067032515Mitral Valve
05415067032508Mitral Valve
05415067032492Mitral Valve
05415067032485Mitral Valve
05415067032478Mitral Valve
05415067032461Mitral Valve
05415067032454Mitral Valve
05415067032447Mitral Valve
05415067032096Stand
054150670320272 lb Weight

Trademark Results [Tendyne]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TENDYNE
TENDYNE
86609447 not registered Live/Pending
Tendyne Holdings, Inc.
2015-04-24
TENDYNE
TENDYNE
85669495 not registered Dead/Abandoned
Tendyne Holdings, Inc.
2012-07-05

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