GUDID 00802526067518

Lead Tunneler Kit

BOSTON SCIENTIFIC CORPORATION

Vascular graft tunneller
Primary Device ID00802526067518
NIH Device Record Key8c62e365-e871-4171-9b00-c0322f164d37
Commercial Distribution Discontinuation2019-01-29
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number6888
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
GS100802526067518 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWPImplantable pulse generator, pacemaker (non-CRT)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00802526067518]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00802526067518]

Moist Heat or Steam Sterilization;Ethylene Oxide


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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