GUDID 00802526497827

Suture Sleeves

BOSTON SCIENTIFIC CORPORATION

Pacing/defibrillation lead suture sleeve
Primary Device ID00802526497827
NIH Device Record Keybb6a877f-8919-423b-8d69-b2a32f991546
Commercial Distribution StatusIn Commercial Distribution
Version Model Number6403
Company DUNS106295384
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100802526497827 [Primary]
GS100802526620607 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVYPermanent defibrillator electrodes

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-26
Device Publish Date2018-08-26

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