PUNCTUA™ CRT-D

GUDID 00802526480911

Cardiac Resynchronization Therapy Defibrillator

BOSTON SCIENTIFIC CORPORATION

Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator
Primary Device ID00802526480911
NIH Device Record Key992471eb-3c64-4f6a-beef-3e36e86f16ab
Commercial Distribution StatusIn Commercial Distribution
Brand NamePUNCTUA™ CRT-D
Version Model NumberN050
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 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 Identifiers

Device Issuing AgencyDevice ID
GS100802526480911 [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 [PUNCTUA™ CRT-D]

00802526480928Cardiac Resynchronization Therapy Defibrillator
00802526480911Cardiac Resynchronization Therapy Defibrillator

Trademark Results [PUNCTUA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PUNCTUA
PUNCTUA
76702688 4179595 Dead/Cancelled
Cardiac Pacemakers, Inc.
2010-04-28

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