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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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EXACTECHGPS - 10885862625601

Mounting Arm – Upper Part 4 positions
Exactech, Inc.
J00065
In Commercial Distribution

  • 10885862625601 ()

  • V2
J00065

  • Robotic surgical navigation system

EXACTECHGPS - 10885862574091

STATION2+
Exactech, Inc.
I00025
In Commercial Distribution

  • 10885862574091 ()

  • V2
I00025

  • Robotic surgical navigation system

EXACTECHGPS - 10885862553331

MOBILE CART
Exactech, Inc.
J00120
In Commercial Distribution

  • 10885862553331 ()

  • V2
J00120

  • 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

EXCELSIUS GPS - 00889095375633

SI-LOK Tap, 8.0mm, GPS
GLOBUS MEDICAL, INC.
6143.2855
In Commercial Distribution

  • 00889095375633 ()


  • Robotic surgical navigation system

EXCELSIUS GPS - 00889095375626

SI-LOK Drill, 10.5mm , GPS
GLOBUS MEDICAL, INC.
6143.2854
In Commercial Distribution

  • 00889095375626 ()


  • Robotic surgical navigation system

EXCELSIUS GPS - 00889095375602

SI-LOK Drill, 8.5mm , GPS
GLOBUS MEDICAL, INC.
6143.2852
In Commercial Distribution

  • 00889095375602 ()


  • Robotic surgical navigation system
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