Genesis (MNS) with Siemens 001-011000-1

GUDID M58800101100010

Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired direction.

STEREOTAXIS, INC.

Robotic surgical navigation system

• Primary Device ID: M58800101100010
• NIH Device Record Key: 23228347-d8a9-48e1-8068-97054b22abee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genesis (MNS) with Siemens
• Version Model Number: 1.1 Siemens
• Catalog Number: 001-011000-1
• Company DUNS: 024942265
• Company Name: STEREOTAXIS, INC.
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com
• Phone: 13146786100
• Email: info@stereotaxis.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M58800101100010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193147

FDA Product Code

• PJB: Catheter Remote Control System

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-28
• Device Publish Date: 2020-08-20

Devices Manufactured by STEREOTAXIS, INC.

• M58800100175110 - QuikCAS Cardiodrive Sterile Components: 2024-07-17 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E
• M5880010017711 - QuikCAS Hemostasis Adapter: 2024-07-17 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E
• M5880010017712 - Cardiodrive Hemostasis Adapter - SJ: 2024-07-17 The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (E
• M58800100230710 - Vdrive System: 2024-07-17 "The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE
• M58800100230720 - Vdrive System: 2024-07-17 "The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE
• M58800100242210 - V-CAS Catheter Advancement System: 2024-07-17 The Vdrive with V-CAS Disposable is indicated for remotely controlling the advancement, retraction, and rotation of compatible m
• M58800100245210 - V-Loop Variable Loop Catheter Manipulator: 2024-07-17 The Vdrive with V-Loop disposable is indicated to remotely control the advancement, retraction, rotation, tip deflection and loo
• M58800100246910 - V-Sono Intracardiac Echo Manipulator: 2024-07-17 Vdrive with V-Sono is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection