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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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EXCELSIUSFLEX - 00193982567910

Articulated Driver Tip
GLOBUS MEDICAL, INC.
6221.2684
In Commercial Distribution

  • 00193982567910 ()


  • Robotic surgical navigation system

EXCELSIUSFLEX - 00193982567903

CT Registration Attachment, EFlex
GLOBUS MEDICAL, INC.
6221.2617
In Commercial Distribution

  • 00193982567903 ()


  • Robotic surgical navigation system

EXCELSIUSFLEX - 00193982567897

Plane Checker Attachment, EFlex
GLOBUS MEDICAL, INC.
6221.2616
In Commercial Distribution

  • 00193982567897 ()


  • Robotic surgical navigation system

EXCELSIUSFLEX - 00193982567880

Sawblade Calibration Attachment, EFlex
GLOBUS MEDICAL, INC.
6221.2615
In Commercial Distribution

  • 00193982567880 ()


  • Robotic surgical navigation system

EXCELSIUSFLEX - 00193982567873

Tibia Hook Attachment, EFlex
GLOBUS MEDICAL, INC.
6221.2614
In Commercial Distribution

  • 00193982567873 ()


  • Robotic surgical navigation system

EXCELSIUSFLEX - 00193982567866

Implant Verification Attachment, EFlex
GLOBUS MEDICAL, INC.
6221.2613
In Commercial Distribution

  • 00193982567866 ()


  • Robotic surgical navigation system

EXCELSIUSFLEX - 00193982567859

Registration Stylus, EFlex
GLOBUS MEDICAL, INC.
6221.2612
In Commercial Distribution

  • 00193982567859 ()


  • Robotic surgical navigation system

EXCELSIUSFLEX - 00193982567842

Quick-Connect Array, EFlex
GLOBUS MEDICAL, INC.
6221.2608
In Commercial Distribution

  • 00193982567842 ()


  • Robotic surgical navigation system

EXCELSIUSFLEX - 00193982567835

Tibia Reference Array, EFlex
GLOBUS MEDICAL, INC.
6221.2607
In Commercial Distribution

  • 00193982567835 ()


  • Robotic surgical navigation system

EXCELSIUSFLEX - 00193982567828

Femur Reference Array, EFlex
GLOBUS MEDICAL, INC.
6221.2602
In Commercial Distribution

  • 00193982567828 ()


  • Robotic surgical navigation system

EXCELSIUSFLEX - 00193982567811

Robot Reference Array, EFlex
GLOBUS MEDICAL, INC.
6221.2601
In Commercial Distribution

  • 00193982567811 ()


  • Robotic surgical navigation system

EXCELSIUSFLEX - 00193982567774

Sawblade Adapter, EFlex
GLOBUS MEDICAL, INC.
6221.2505
In Commercial Distribution

  • 00193982567774 ()


  • Robotic surgical navigation system

AESCULAP - 04046963067359

ORTHOPILOT DISPOS.PASSIVE MARKER STERILE
Aesculap AG
FS617
In Commercial Distribution

  • 04046963067359 ()
  • 04038653457304 ()
FS617

  • Robotic surgical navigation system

AESCULAP - 04046963188849

ORTHOPILOT FOOT SWITCH F/COMPACT & FLEX
Aesculap AG
FS007
Not in Commercial Distribution

  • 04046963188849 ()
FS007

  • 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

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 - 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

Short Navigation Probe - 03760305400079

The Navigation Probe is an instrument of the EPIONE device. It enables visualizing reference points or anatomical landmarks in the medical images. It allows the verification of patient registration accuracy, using external anatomical landmarks or skin markers.
QUANTUM SURGICAL
02-0044
In Commercial Distribution

  • 03760305400079 ()
02-0044

  • Robotic surgical navigation system

Navigation probe - 03760305400055

The Navigation Probe is an instrument of the EPIONE device. It enables visualizing reference points or anatomical landmarks in the medical images. It allows the verification of patient registration accuracy, using external anatomical landmarks or skin markers.
QUANTUM SURGICAL
02-0031
Not in Commercial Distribution

  • 03760305400055 ()
02-0031

  • Robotic surgical navigation system
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