Genesis MNS with Model-S 001-011000-3

GUDID M58800101100030

Robotic surgical navigation system

Primary Device ID	M58800101100030
NIH Device Record Key	888c8dad-7934-4641-810e-6a929b829ae8
Commercial Distribution Status	In Commercial Distribution
Brand Name	Genesis MNS with Model-S
Version Model Number	1.1 Model-S
Catalog Number	001-011000-3
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

Device Issuing Agency	Device ID
HIBCC	M58800101100030 [Primary]

PJB	Catheter Remote Control System

Steralize Prior To Use	false
Device Is Sterile	false

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