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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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CUVIS-spine - 08800043830020

No Description
CUREXO, Inc.
CS200
In Commercial Distribution

  • 08800043830020 ()


  • Robotic surgical navigation system

CUVIS-spine - 08800043830013

No Description
CUREXO, Inc.
CS100
In Commercial Distribution

  • 08800043830013 ()
CA-00000-000

  • Robotic surgical navigation system

N/A - 08800043830006

No Description
CUREXO, Inc.
CUVIS-spine
In Commercial Distribution

  • 08800043830006 ()
CA-00000-000

  • 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

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

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

VELYS - 10705034646008

VELYS™ Robotic-Assist Station
Medos International Sàrl
451611001
In Commercial Distribution

  • 10705034646008 ()
451611001

  • Robotic surgical navigation system

VELYS - 10705034643472

VELYS™ TOOL HOLDER L
Medos International Sàrl
451611032
In Commercial Distribution

  • 10705034643472 ()
451611032

  • Robotic surgical navigation system

VELYS - 10705034646015

VELYS™ Camera Station
Medos International Sàrl
451611002
In Commercial Distribution

  • 10705034646015 ()
451611002

  • Robotic surgical navigation system

VELYS - 10705034645995

VELYS™ Navigation Station
Medos International Sàrl
451611000
In Commercial Distribution

  • 10705034645995 ()
451611000

  • Robotic surgical navigation system

VELYS - 10705034643496

VELYS™ TOOL HOLDER S
Medos International Sàrl
451611030
In Commercial Distribution

  • 10705034643496 ()
451611030

  • Robotic surgical navigation system

VELYS - 10705034643489

VELYS™ TOOL HOLDER M
Medos International Sàrl
451611031
In Commercial Distribution

  • 10705034643489 ()
451611031

  • Robotic surgical navigation system

VELYS - 10705034643335

VELYS SPINE DRAPE CAP
Medos International Sàrl
451611063
In Commercial Distribution

  • 10705034643335 ()
451611063

  • Robotic surgical navigation system

EXCELSIUS GPS - 00889095375640

SI-LOK Tap, 10.0mm, GPS
GLOBUS MEDICAL, INC.
6143.2856
In Commercial Distribution

  • 00889095375640 ()


  • 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 - 00889095375619

SI-LOK Drill, 9.5mm , GPS
GLOBUS MEDICAL, INC.
6143.2853
In Commercial Distribution

  • 00889095375619 ()


  • 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

EXCELSIUS GPS - 00889095375589

SI-LOK Drill, 6.5mm , GPS
GLOBUS MEDICAL, INC.
6143.2850
In Commercial Distribution

  • 00889095375589 ()


  • Robotic surgical navigation system
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