GUDID 00802526066719

Lead Pulling Tip STL IS-1/DF-1

BOSTON SCIENTIFIC CORPORATION

Pacing/defibrillation lead tunneller
Primary Device ID00802526066719
NIH Device Record Keyba7121a9-49db-4ab8-8380-a1534a7da50c
Commercial Distribution Discontinuation2019-01-29
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number6804
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
GS100802526066719 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWSImplantable cardioverter defibrillator (non-CRT)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00802526066719]

Ethylene Oxide;Moist Heat or Steam Sterilization


[00802526066719]

Ethylene Oxide;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-15
Device Publish Date2014-09-24

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