GUDID 00802526077494

Telemetry wand

BOSTON SCIENTIFIC CORPORATION

Cardiac pulse generator programmer
Primary Device ID00802526077494
NIH Device Record Keya92e1476-9fb6-44ea-ab54-2e1b0f185281
Commercial Distribution StatusIn Commercial Distribution
Version Model Number6577
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100802526077494 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWSImplantable cardioverter defibrillator (non-CRT)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-30
Device Publish Date2014-09-24

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

08714729877769 - Orbiter™ ST2024-12-20 Bidirectional Steerable Diagnostic Catheter
08714729877776 - Orbiter™ ST2024-12-20 Bidirectional Steerable Diagnostic Catheter
08714729877783 - Orbiter™ ST2024-12-20 Bidirectional Steerable Diagnostic Catheter
08714729877806 - Orbiter™ ST2024-12-20 Bidirectional Steerable Diagnostic Catheter
08714729877813 - Orbiter™ ST2024-12-20 Bidirectional Steerable Diagnostic Catheter
08714729877820 - Orbiter™ ST2024-12-20 Bidirectional Steerable Diagnostic Catheter
08714729877837 - Orbiter™ ST2024-12-20 Bidirectional Steerable Diagnostic Catheter
08714729877844 - Orbiter™ ST2024-12-20 Bidirectional Steerable Diagnostic Catheter

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