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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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Monarch™ Software Tower v2.1.5
AURIS HEALTH, INC.
Version 2.1.5
In Commercial Distribution

  • B634SW0032740201050 ()


  • Robotic surgical system application software
Monarch™ Software Tower v2.1.4
AURIS HEALTH, INC.
Version 2.1.4
In Commercial Distribution

  • B634SW0032740201040 ()


  • Robotic surgical system application software
Monarch™ Software Tower v2.1.3
AURIS HEALTH, INC.
Version 2.1.3
In Commercial Distribution

  • B634SW0032740201030 ()


  • Robotic surgical system application software
Monarch™ Software Tower v2.1.2
AURIS HEALTH, INC.
Version 2.1.2
In Commercial Distribution

  • B634SW0032740201020 ()


  • Robotic surgical system application software
Monarch™ Laptop P16 Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811527 ()


  • Robotic surgical system application software
Monarch™ Laptop P17 Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811510 ()


  • Robotic surgical system application software
Monarch™ Cart Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811503 ()


  • Robotic surgical system application software
Monarch™ Tower Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811497 ()


  • Robotic surgical system application software
Monarch™ Laptop P17/P73 Linux USB Image v2.2.5
AURIS HEALTH, INC.
Version 2.2.5
In Commercial Distribution

  • 10810068810797 ()


  • Robotic surgical system application software
Monarch™ Laptop P70 Linux USB Image v2.2.5
AURIS HEALTH, INC.
Version 2.2.5
In Commercial Distribution

  • 10810068810780 ()


  • Robotic surgical system application software
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