GUDID 00802526497803

Suture Sleeves

BOSTON SCIENTIFIC CORPORATION

Pacing/defibrillation lead suture sleeve
Primary Device ID00802526497803
NIH Device Record Key30a0f0a2-39d7-491a-abf3-a49b76312985
Commercial Distribution StatusIn Commercial Distribution
Version Model Number6402
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
GS100802526497803 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVNDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-11
Device Publish Date2016-05-10

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