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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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PCH2OO Stand Alone Software, Expert Holter
WELCH ALLYN, INC.
901052
Not in Commercial Distribution

  • 00732094128444 ()
704527

  • Electrocardiograph, professional, multichannel
SOFTWARE COMP GPS 4.7 USB PACKAGE
Widex A/S
Compass GPS 4.7
In Commercial Distribution

  • 05714880239140 ()
21038004

  • Audiometric/hearing device software
SOFTWARE COMP GPS 4.5 DVD PACKAGE
Widex A/S
Compass GPS 4.5
In Commercial Distribution

  • 05714880204070 ()
21027791

  • Audiometric/hearing device software
3CPM EGGSAS Waterload Interface (Software Only)
3CPM CO., INC.
2.09g
In Commercial Distribution

  • 00864359000285 ()


  • Myoelectric gastrointestinal motility analysis system
3CPM EGGSAS Research Interface (Software Only)
3CPM CO., INC.
2.09g
In Commercial Distribution

  • 00864359000247 ()


  • Myoelectric gastrointestinal motility analysis system
IMAGEXL XRAY SOFTWARE VERSION 4 BASE
PROFESSIONAL ECONOMICS BUREAU OF AMERICA INC
4
In Commercial Distribution

  • 00861787000306 ()


  • General-purpose dental x-ray system application software
SOFTWARE 8263005 ACCUGUIDE MONIT V2.0 CD
MEDTRONIC XOMED, INC.
8263005
In Commercial Distribution

  • 00613994161635 ()


  • Nerve-locating system
SWR KIT SSPRO SOFTWARE VER 11
VYAIRE MEDICAL, INC.
28008-001
In Commercial Distribution

  • 10190752161993 ()
28008-001

  • Home-use sleep apnoea recording system
OptiBolus, Bolus Shaping Software, International (Accessory)
Liebel-Flarsheim Company LLC
844210
In Commercial Distribution

  • 10746190004813 ()


  • CT contrast medium injection system, line-powered, stationary
OptiBolus, Bolus Shaping Software, Domestic (Accessory)
Liebel-Flarsheim Company LLC
844200
In Commercial Distribution

  • 10746190004806 ()


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