PUNCTUA™ ICD

GUDID 00802526480690

Implantable Cardioverter Defibrillator

BOSTON SCIENTIFIC CORPORATION

Dual-chamber implantable defibrillator
Primary Device ID00802526480690
NIH Device Record Keyab9996f4-731b-476a-aff5-f9623fe887af
Commercial Distribution StatusIn Commercial Distribution
Brand NamePUNCTUA™ ICD
Version Model NumberE052
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
GS100802526480690 [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™ ICD]

00802526480706Implantable Cardioverter Defibrillator
00802526480690Implantable Cardioverter Defibrillator
00802526480683Implantable Cardioverter Defibrillator
00802526480676Implantable Cardioverter Defibrillator

Trademark Results [PUNCTUA]

Mark Image

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.