GUDID 00802526585838

BATTERY

BOSTON SCIENTIFIC CORPORATION

Rechargeable battery pack
Primary Device ID00802526585838
NIH Device Record Key9e45a196-0513-4973-b224-8e35aadd95a4
Commercial Distribution StatusIn Commercial Distribution
Version Model Number6753
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100802526585838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OSRPacemaker/icd/crt non-implanted components

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-20

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

00802526618208 - myLUX™ Patient App2025-04-21 For Insertable Cardiac Monitor
00802526618215 - myLUX™ Patient App2025-04-21 for Insertable Cardiac Monitor
00191506046330 - Sterling™2025-03-31 PTA Balloon Dilatation Catheter
00191506046347 - Sterling™2025-03-31 PTA Balloon Dilatation Catheter
00191506046354 - Sterling™2025-03-31 PTA Balloon Dilatation Catheter
00191506046361 - Sterling™2025-03-31 PTA Balloon Dilatation Catheter
00191506046378 - Sterling™2025-03-31 PTA Balloon Dilatation Catheter
00191506046385 - Sterling™2025-03-31 PTA Balloon Dilatation Catheter

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.