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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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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

QuikCAS Cardiodrive Sterile Components - M58800100175110

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

  • M58800100175110 ()
001-001751-1

  • 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

DCTclock - B62611100

DCTclock System
Linus Health, Inc.
1110
In Commercial Distribution

  • B62611100 ()
1110

  • Drawing-test cognitive function analysis device

DCTclock - B626100960

DCTclock System - Research
Linus Health, Inc.
10096
In Commercial Distribution

  • B626100960 ()
10096

  • Drawing-test cognitive function analysis device

DCTclock - B626100930

DCTclock Practice Test Form - clinical
Linus Health, Inc.
10093
In Commercial Distribution

  • B626100931 ()
  • B626100930 ()
10093

  • Drawing-test cognitive function analysis device

DCTclock - B626100720

DCTclock Test Form - Clinical
Linus Health, Inc.
10072
In Commercial Distribution

  • B626100722 ()
  • B626100721 ()
  • B626100720 ()
10072

  • Drawing-test cognitive function analysis device

DCTclock - B626100390

DCTclock Practice Test Form - Research
Linus Health, Inc.
10039
In Commercial Distribution

  • B626100391 ()
  • B626100390 ()
10039

  • Drawing-test cognitive function analysis device

DCTclock - B626100150

DCTclock Cloud Platform
Linus Health, Inc.
10015
In Commercial Distribution

  • B626100150 ()
10015

  • Drawing-test cognitive function analysis device

DCTclock - B626100060

DCTclock Micro USB Cable
Linus Health, Inc.
10006
In Commercial Distribution

  • B626100060 ()
10006

  • Drawing-test cognitive function analysis device
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