Vis-Rx

GUDID 00859910007018

Coronary optical coherence tomography system catheter

Primary Device ID	00859910007018
NIH Device Record Key	31fb342e-3ed1-4238-94a7-0df7e61d8e92
Commercial Distribution Status	In Commercial Distribution
Brand Name	Vis-Rx
Version Model Number	US Catheter Kit G30-01
Company DUNS	077509759
Company Name	GENTUITY LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00859910007018 [Primary]

DQO	Catheter, Intravascular, Diagnostic

Steralize Prior To Use	false
Device Is Sterile	true

00859910007049 - Gentuity	2022-08-25 Gentuity Off-line Review Station includes computer, monitor, keyboard, and mouse.
00859910007032 - Gentuity HF-OCT Imaging System	2021-06-30 Gentuity OCT imaging console, including optical engine, PC, PIM with umbilical, 2 monitors (one with touch screen) and keyboard/
00859910007018 - Vis-Rx	2021-02-191.8F Rapid exchange micro-imaging high frequency OCT catheter kit - US
00859910007018 - Vis-Rx	2021-02-19 1.8F Rapid exchange micro-imaging high frequency OCT catheter kit - US

Mark Image Registration \| Serial	Company Trademark Application Date
VIS-RX 87209907 5601930 Live/Registered	Gentuity, LLC 2016-10-20