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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Odyssey Cinema - M58800100784010

The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab
Stereotaxis, Inc.
Studio
In Commercial Distribution

  • M58800100784010 ()
001-007840-1

  • Cardiac mapping system workstation

Niobe MNS Philips - M58800100610010

Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Workstation. The Niobe MNS with Navigant NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction
Stereotaxis, Inc.
ES Philips
In Commercial Distribution

  • M58800100610010 ()
001-006100-1

  • Cardiac mapping system workstation

Niobe Cover Drape - M58800100591011

Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Workstation. The Niobe MNS with Navigant NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction
Stereotaxis, Inc.
1
Not in Commercial Distribution

  • M58800100591011 ()
  • M58800100591010 ()
001-005910-1

  • Cardiac mapping system workstation

V-Loop Variable Loop Catheter Manipulator - M58800100245210

The Vdrive with V-Loop disposable is indicated to remotely control the advancement, retraction, rotation, tip deflection and loop size of compatibile loop catheters inserted across the septum into the left atrium using conventional procedures
Stereotaxis, Inc.
1
In Commercial Distribution

  • M58800100245210 ()
001-002452-1

  • Cardiac mapping system workstation

Vdrive System - M58800100230710

"The Vdrive® system is intended to stabilize, navigate and remotely control: • Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during the performance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, • Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance of electrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and • Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when used in conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic Navigation System (MNS). "
Stereotaxis, Inc.
Single Arm
In Commercial Distribution

  • M58800100230710 ()
001-002307-1

  • Cardiac mapping system workstation

QuikCAS Hemostasis Adapter - M5880010017711

The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.
Stereotaxis, Inc.
1
In Commercial Distribution

  • M5880010017711 ()
  • M58803000177110 ()
001-001771-1

  • Cardiac mapping system workstation

Hemostasis Adapter - M58800100111411

Hemostasis Adapter IV Spares, Box, Device Count(5)
Stereotaxis, Inc.
IV-1
In Commercial Distribution

  • M58800100111410 ()
  • M58800100111411 ()
0010011141

  • Cardiac mapping system workstation

Navigant - M588020004500360

The Navigant Navigation Workstation (NWS) is a component of the Magnetic Navigation System (MNS). The MNS with NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant feature provides an enhanced navigation interface for the physician to control the MNS.
Stereotaxis, Inc.
5.0.7
In Commercial Distribution

  • M588020004500360 ()
020-004500-36

  • Cardiac mapping system workstation

Odyssey - M58800100790010

The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab
Stereotaxis, Inc.
Link
In Commercial Distribution

  • M58800100790010 ()
001-007900-1

  • Cardiac mapping system workstation

Odyssey Enterprise Interface - M58800100781010

The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab
Stereotaxis, Inc.
EIF
In Commercial Distribution

  • M58800100781010 ()
001-007810-1

  • Cardiac mapping system workstation
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