GUDID 00802526440908

Antenna

BOSTON SCIENTIFIC CORPORATION

Cardiac pulse generator programmer
Primary Device ID00802526440908
NIH Device Record Key9255979f-1a89-4e69-aa5e-2abf1e07e06a
Commercial Distribution StatusIn Commercial Distribution
Version Model Number3122
Company DUNS106295384
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
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
GS100802526440908 [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 Number3
Public Version Date2018-07-06
Device Publish Date2014-09-24

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

08714729195573 - RotaWire™ and wireClip™ Torquer2026-03-31 Guidewire and Guidewire Manipulation Device
08714729195566 - RotaWire™ and wireClip™ Torquer2026-03-31 Guidewire and Guidewire Manipulation Device
08714729837527 - Stingray™2026-03-31 Guidewire with Hydrophilic Coating
08714729877523 - EP XT™2026-03-20 Unidirectional Steerable Diagnostic Catheter
08714729877714 - Dynamic XT™2026-03-20 Unidirectional Steerable Diagnostic Catheter
08714729879947 - EP XT™2026-03-20 Unidirectional Steerable Diagnostic Catheter
08714729181088 - Percuflex™ Biliary2026-03-19 Biliary Stent with Introducer Kit
08714729181095 - Percuflex™ Biliary2026-03-19 Biliary Stent with Introducer Kit

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.