EASYTRAK® 3 IS-1

GUDID 00802526420276

Coronary Venous Steroid-Eluting Bipolar Pace/Sense Lead

BOSTON SCIENTIFIC CORPORATION

Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead
Primary Device ID00802526420276
NIH Device Record Key6eda0058-f8ae-4447-a4c9-bd1102f7d9c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameEASYTRAK® 3 IS-1
Version Model Number4548
Company DUNS106295384
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS100802526420276 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWPImplantable pulse generator, pacemaker (non-CRT)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-24

On-Brand Devices [EASYTRAK® 3 IS-1]

00802526420511Coronary Venous Steroid-eluting Bipolar Pace/Sense Lead
00802526420399Coronary Venous Steroid-Eluting Bipolar Pace/Sense Lead
00802526420276Coronary Venous Steroid-Eluting Bipolar Pace/Sense Lead

Trademark Results [EASYTRAK]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EASYTRAK
EASYTRAK
75496122 2349078 Live/Registered
Cardiac Pacemakers, Inc.
1998-06-04

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