OptiCross

GUDID 08714729841531

40 MHz Coronary Imaging Catheter

BOSTON SCIENTIFIC CORPORATION

Intravascular ultrasound imaging catheter, single-use
Primary Device ID08714729841531
NIH Device Record Keyfa67c9e0-2e64-436b-a998-04d649a56234
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptiCross
Version Model NumberH749518120
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
GS108714729841531 [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]

0871472989039340 MHz Coronary Imaging Catheter
0871472984787840 MHz Coronary Imaging Catheter
0871472984224840 MHz Imaging Catheter
0871472984153140 MHz Coronary Imaging Catheter

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.