ENDOTAK RELIANCE® G

GUDID 00802526531217

Steroid-Eluting Bipolar Pace/Sense and Defibrillation Lead

BOSTON SCIENTIFIC CORPORATION

Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead
Primary Device ID00802526531217
NIH Device Record Key0393cb3c-871d-471f-ac36-f41d8983eba3
Commercial Distribution StatusIn Commercial Distribution
Brand NameENDOTAK RELIANCE® G
Version Model Number0187
Company DUNS106295384
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100802526531217 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWSImplantable cardioverter defibrillator (non-CRT)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-09-09
Device Publish Date2014-09-24

On-Brand Devices [ENDOTAK RELIANCE® G]

00802526531279Steroid-eluting Bipolar Pace/Sense and Defibrillation Lead
00802526531262Steroid-eluting Bipolar Pace/Sense and Defibrillation Lead
00802526531217Steroid-Eluting Bipolar Pace/Sense and Defibrillation Lead
00802526531200Steroid-Eluting Bipolar Pace/Sense and Defibrillation Lead
00802526531194Steroid-Eluting Bipolar Pace/Sense and Defibrillation Lead
00802526531187Steroid-Eluting Bipolar Pace/Sense and Defibrillation Lead
00802526431418Steroid-eluting Bipolar Pace/Sense and Defibrillation Lead
00802526431401Steroid-eluting Bipolar Pace/Sense and Defibrillation Lead
00802526376818Steroid-Eluting Bipolar Pace/Sense and Defibrillation Lead
00802526376726Steroid-Eluting Bipolar Pace/Sense and Defibrillation Lead
00802526373732Steroid-Eluting Bipolar Pace/Sense and Defibrillation Lead
00802526373640Steroid-Eluting Bipolar Pace/Sense and Defibrillation Lead

Trademark Results [ENDOTAK RELIANCE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENDOTAK RELIANCE
ENDOTAK RELIANCE
75920645 2530595 Live/Registered
Cardiac Pacemakers, Inc.
2000-02-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.