OptiCross™ 6 HD H74939354070

GUDID 08714729960805

Coronary Imaging Catheter


Intravascular ultrasound imaging catheter, single-use
Primary Device ID08714729960805
NIH Device Record Key504be0a5-8b0e-469b-abdf-33b00660a469
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptiCross™ 6 HD
Version Model NumberH74939354070
Catalog NumberH74939354070
Company DUNS021717889
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 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
GS108714729960805 [Primary]

FDA Product Code

OBJCatheter, ultrasound, intravascular


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 Date2018-02-06

On-Brand Devices [OptiCross™ 6 HD]

08714729960805Coronary Imaging Catheter
08714729960775Coronary Imaging Catheter

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