Vis-Rx

GUDID 00859910007018

1.8F Rapid exchange micro-imaging high frequency OCT catheter kit - US

GENTUITY LLC

Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter 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 Dimensions

• Catheter Gauge: 1.8 French
• Catheter Gauge: 1.8 French
• Catheter Gauge: 1.8 French
• Catheter Gauge: 1.8 French
• Catheter Gauge: 1.8 French
• Catheter Gauge: 1.8 French
• Catheter Gauge: 1.8 French
• Catheter Gauge: 1.8 French
• Catheter Gauge: 1.8 French
• Catheter Gauge: 1.8 French
• Catheter Gauge: 1.8 French
• Catheter Gauge: 1.8 French
• Catheter Gauge: 1.8 French
• Catheter Gauge: 1.8 French
• Catheter Gauge: 1.8 French
• Catheter Gauge: 1.8 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859910007018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192922

FDA Product Code

• DQO: Catheter, Intravascular, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-19
• Device Publish Date: 2021-02-11

Devices Manufactured by GENTUITY LLC

• 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