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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™ Laptop P17/P73 Linux USB Image v2.2.4 - 10810068810506

Monarch™ Laptop P17/P73 Linux USB Image v2.2.4
AURIS HEALTH, INC.
Version 2.2.4
In Commercial Distribution

  • 10810068810506 ()


  • Robotic surgical system application software

Monarch™ Laptop P70 Linux USB Image v2.2.4 - 10810068810490

Monarch™ Laptop P70 Linux USB Image v2.2.4
AURIS HEALTH, INC.
Version 2.2.4
In Commercial Distribution

  • 10810068810490 ()


  • Robotic surgical system application software

Monarch™ Software Cart v2.2.4 - 10810068810483

Monarch™ Software Cart v2.2.4
AURIS HEALTH, INC.
Version 2.2.4
In Commercial Distribution

  • 10810068810483 ()


  • Robotic surgical system application software

Monarch™ Software Tower v2.2.4 - 10810068810476

Monarch™ Software Tower v2.2.4
AURIS HEALTH, INC.
Version 2.2.4
In Commercial Distribution

  • 10810068810476 ()


  • Robotic surgical system application software

EmpowerCTA®+ Injector System 1731 ed03 - 47630039301444

Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector
Bracco Injeneering SA
017285
In Commercial Distribution

  • 47630039301444 ()


  • CT contrast medium injection system, line-powered, stationary

EmpowerCTA®+ Injector System - 47630039301437

Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector
Bracco Injeneering SA
017285
In Commercial Distribution

017285

  • CT contrast medium injection system, line-powered, stationary

EmpowerCTA®+ Injector System - 47630039301000

Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector
Bracco Injeneering SA
017285
Not in Commercial Distribution



  • CT contrast medium injection system, line-powered, stationary

uMI - 06971576832057

No Description
Shanghai United Imaging Healthcare Co., Ltd.
uMI 550
In Commercial Distribution

  • 06971576832057 ()


  • PET/CT system

uMI - 06971576832026

Positron Emission Tomography and Computed Tomography System
Shanghai United Imaging Healthcare Co., Ltd.
uMI 550
In Commercial Distribution

  • 06971576832026 ()


  • PET/CT system

Remote Control - 17630039302051

EmpowerCTA+ Injector System, Remote Control
Bracco Injeneering SA
102409
In Commercial Distribution

  • 37630039302048 ()
  • 17630039302051 ()


  • CT contrast medium injection system, line-powered, stationary
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