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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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iotaSOFT Insertion System - 00850002960068

iotaSOFT Plus Drive Unit
Iotamotion, Inc.
IM-05
In Commercial Distribution

  • 00850002960068 ()


  • Robotic surgical system application software

iotaSOFT Insertion System - 00850002960051

iotaSOFT Control Console
Iotamotion, Inc.
IM-01
In Commercial Distribution

  • 00850002960051 ()


  • Robotic surgical system application software

iotaSOFT Insertion System - 00850002960044

iotaSOFT Rolling Stand
Iotamotion, Inc.
IM-04
In Commercial Distribution

  • 00850002960044 ()


  • Robotic surgical system application software

iotaSOFT Insertion System - 00850002960037

iotaSOFT Footpedal
Iotamotion, Inc.
IM-03
In Commercial Distribution

  • 00850002960037 ()


  • Robotic surgical system application software

iotaSOFT Insertion System - 00850002960020

iotaSOFT Console
Iotamotion, Inc.
IM-02
In Commercial Distribution

  • 00850002960020 ()


  • Robotic surgical system application software

iotaSOFT Insertion System - 00850002960006

iotaSOFT Drive Unit
Iotamotion, Inc.
IM-00
In Commercial Distribution

  • 00850002960006 ()


  • Robotic surgical system application software

Monarch™ Laptop P16 Software v4.1.1 - 10810068811527

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 - 10810068811510

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 - 10810068811503

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 - 10810068811497

Monarch™ Tower Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811497 ()


  • Robotic surgical system application software
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