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

  • 10810068811510 ()


  • Robotic surgical system application software
Monarch™ Laptop P16 Software v4.1.0
AURIS HEALTH, INC.
Version 4.1.0
In Commercial Distribution

  • 10810068810612 ()


  • Robotic surgical system application software
Monarch™ Laptop P17 Software v4.1.0
AURIS HEALTH, INC.
Version 4.1.0
In Commercial Distribution

  • 10810068810605 ()


  • Robotic surgical system application software
MR Applications Software for MP24 R03
GENERAL ELECTRIC COMPANY
MP24 R03
Not in Commercial Distribution

  • 00840682124591 ()


  • MRI system application software
SenoIris 1 SP4.5 Software and Manuals
GE MEDICAL SYSTEMS
1
In Commercial Distribution

  • 00840682147767 ()


  • Diagnostic x-ray digital imaging system workstation
SenoIris 1 SP3.2 Software and Manuals
GE Healthcare GmbH
1
Not in Commercial Distribution

  • 00840682140614 ()


  • Diagnostic x-ray digital imaging system workstation
SOFTWARE GE CLIENT WORKSTATION V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123594 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
SenoIris 1 SP2.2 Software and Manuals
GE Healthcare GmbH
1
Not in Commercial Distribution

  • 00840682104395 ()


  • Diagnostic x-ray digital imaging system workstation
KIT,AVEA UPGRADE GDE,UIM & SOFTWARE
Carefusion Corporation
12283-PMN
Not in Commercial Distribution

  • 10846446064865 ()


  • Ventilator application software
SWR KIT SSPRO SOFTWARE VER 10.2
Carefusion Corporation
22312-001
Not in Commercial Distribution

  • 10846446031485 ()
22312-001

  • Home-use sleep apnoea recording system
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