EASYTRAK® 2 IS-1

GUDID 00802526410994

Coronary Venous Steroid-Eluting Bipolar Pace/Sense Lead

BOSTON SCIENTIFIC CORPORATION

Endocardial pacing lead
Primary Device ID00802526410994
NIH Device Record Key595736f1-3a51-4678-9f95-3a6063dc6910
Commercial Distribution StatusIn Commercial Distribution
Brand NameEASYTRAK® 2 IS-1
Version Model Number4543
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS100802526410994 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

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® 2 IS-1]

00802526579820Coronary Venous Steroid-Eluting Dual Electrode Pace/Sense Lead
00802526579813Coronary Venous Steroid-Eluting Dual Electrode Pace/Sense Lead
00802526579806Coronary Venous Steroid-Eluting Dual Electrode Pace/Sense Lead
00802526411083Coronary Venous Steroid-Eluting Bipolar Pace/Sense Lead
00802526410994Coronary Venous Steroid-Eluting Bipolar Pace/Sense Lead
00802526410901Coronary 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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