OptiCross 6

GUDID 08714729904755

Coronary Imaging Catheter

BOSTON SCIENTIFIC CORPORATION

Intravascular ultrasound imaging catheter, single-use
Primary Device ID08714729904755
NIH Device Record Key7b6d918b-7c3f-4050-85e1-5cb1339d2cd4
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptiCross 6
Version Model NumberH7495181060
Company DUNS021717889
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 Kittrue
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 Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS108714729904755 [Primary]

FDA Product Code

OBJCatheter, ultrasound, intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-11
Device Publish Date2016-09-24

On-Brand Devices [OptiCross 6]

08714729904762Coronary Imaging Catheter
08714729904755Coronary Imaging Catheter

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.