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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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TMINI™ Navigation Console - M9461087570

No Description
THINK SURGICAL, INC.
108757
In Commercial Distribution

  • M9461087570 ()
108757

  • Robotic surgical navigation system

Sesamoid - 00889024305205

No Description
Orthosoft Inc
20-8000-070-64
Not in Commercial Distribution

  • 00889024305205 ()
20-8000-070-64

  • Robotic surgical navigation system

Sesamoid - 00889024305120

No Description
Orthosoft Inc
20-8000-070-39
In Commercial Distribution

  • 00889024305120 ()
20-8000-070-39

  • Robotic surgical navigation system

Sesamoid - 00889024305113

No Description
Orthosoft Inc
20-8000-070-38
In Commercial Distribution

  • 00889024305113 ()
20-8000-070-38

  • Robotic surgical navigation system

Sesamoid - 00889024305106

No Description
Orthosoft Inc
20-8000-070-37
Not in Commercial Distribution

  • 00889024305106 ()
20-8000-070-37

  • Robotic surgical navigation system

Sesamoid - 00889024305083

No Description
Orthosoft Inc
20-8000-070-35
Not in Commercial Distribution

  • 00889024305083 ()
20-8000-070-35

  • Robotic surgical navigation system

Genesis MNS with Model-S - M58800101100030

"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.
1.1 Model-S
In Commercial Distribution

  • M58800101100030 ()
001-011000-3

  • Robotic surgical navigation system

Genesis (RMNS) - M58800101100010

Genesis RMNS 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.
1.1
In Commercial Distribution

  • M58800101100010 ()
001-011000-1

  • Robotic surgical navigation system

Cardiodrive System - M588001004115120

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.
II
In Commercial Distribution

  • M588001004115120 ()
001-004115-12

  • Robotic surgical navigation system

Cardiodrive System - M588001004115110

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.
II
In Commercial Distribution

  • M588001004115110 ()
001-004115-11

  • Robotic surgical navigation system
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