INGEVITY™ MRI

GUDID 00802526523458

Endocardial Steroid-eluting MR Conditional Stylet delivered 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 Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead
Primary Device ID00802526523458
NIH Device Record Keyd78db3c4-7a38-4784-928b-a73071666895
Commercial Distribution StatusIn Commercial Distribution
Brand NameINGEVITY™ MRI
Version Model Number7741
Company DUNS106295384
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
GS100802526523458 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVNDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-06-07
Device Publish Date2016-05-10

On-Brand Devices [INGEVITY™ MRI]

00802526523489Endocardial Steroid-eluting MR Conditional Stylet delivered Pace/Sense Lead
00802526523458Endocardial Steroid-eluting MR Conditional Stylet delivered Pace/Sense Lead
00802526523427Endocardial Steroid-eluting MR Conditional Stylet delivered Pace/Sense Lead
00802526523397Endocardial Steroid-eluting MR Conditional Stylet delivered Pace/Sense Lead
00802526523366Endocardial Steroid-eluting MR Conditional Stylet delivered Pace/Sense Lead
00802526523335Endocardial Steroid-eluting MR Conditional Stylet delivered Pace/Sense Lead
00802526523304Endocardial Steroid-eluting MR Conditional Stylet delivered Pace/Sense Lead

Trademark Results [INGEVITY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INGEVITY
INGEVITY
86827644 5088206 Live/Registered
Ingevity South Carolina, LLC
2015-11-20
INGEVITY
INGEVITY
86821741 5092710 Live/Registered
Cardiac Pacemakers, Inc.
2015-11-16
INGEVITY
INGEVITY
86748345 5087931 Live/Registered
INGEVITY SOUTH CAROLINA, LLC
2015-09-04
INGEVITY
INGEVITY
86748336 5087930 Live/Registered
INGEVITY SOUTH CAROLINA, LLC
2015-09-04
INGEVITY
INGEVITY
86748323 5087929 Live/Registered
INGEVITY SOUTH CAROLINA, LLC
2015-09-04
INGEVITY
INGEVITY
86748312 5087928 Live/Registered
INGEVITY SOUTH CAROLINA, LLC
2015-09-04
INGEVITY
INGEVITY
85677818 not registered Dead/Abandoned
Cardiac Pacemakers, Inc.
2012-07-16
INGEVITY
INGEVITY
77162011 3411432 Dead/Cancelled
Burns, Fraser C
2007-04-20
INGEVITY
INGEVITY
76694769 not registered Dead/Abandoned
Cardiac Pacemakers, Inc.
2008-12-12

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