GUDID 00802526489433

LV-1 Lead Cap

BOSTON SCIENTIFIC CORPORATION

Pacing/defibrillation lead cap Pacing/defibrillation lead cap Pacing/defibrillation lead cap Pacing/defibrillation lead cap Pacing/defibrillation lead cap Pacing/defibrillation lead cap Pacing/defibrillation lead cap Pacing/defibrillation lead cap Pacing/defibrillation lead cap Pacing/defibrillation lead cap Pacing/defibrillation lead cap Pacing/defibrillation lead cap Pacing/defibrillation lead cap
Primary Device ID00802526489433
NIH Device Record Keyaf6de383-84f9-45f9-a3b8-41107ab56191
Commercial Distribution StatusIn Commercial Distribution
Version Model Number6742
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 Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100802526489433 [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

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