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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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Cardiology Data Software
MORTARA INSTRUMENT, INC.
11111-002-51    
In Commercial Distribution

  • 00817655020259 ()


  • Cardiology information system application software
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11111-002-50    
In Commercial Distribution

  • 00817655020242 ()


  • Cardiology information system application software
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-011-51
In Commercial Distribution

  • 00817655022802 ()


  • Patient health record information system
TL-HEX APPLICATION SOFTWARE
ORTHOFIX SRL
01
In Commercial Distribution

  • 18054242511847 ()
TLHEXSW

  • External orthopaedic fixation frame calculation software
SmartPill software v3.1
Given Imaging, Inc.
FGS-0658
In Commercial Distribution

  • 07290110360481 ()


  • Gastrointestinal telemetric monitoring system
v3.0 software kit
Given Imaging, Inc.
FGS-0571
In Commercial Distribution

  • 07290101365921 ()


  • Manometric gastrointestinal motility analysis system
v3.0.1 Software kit
Given Imaging, Inc.
FGS-8028
In Commercial Distribution

  • 07290101365778 ()


  • Manometric gastrointestinal motility analysis system
ManoScan ESO Software
Given Imaging, Inc.
800022
In Commercial Distribution

  • 07290101365754 ()


  • Manometric gastrointestinal motility analysis system
ManoScan AR Software
Given Imaging, Inc.
800024
In Commercial Distribution

  • 07290101364009 ()


  • Manometric gastrointestinal motility analysis system
Device Services Software
BOSTON SCIENTIFIC CORPORATION
7260
In Commercial Distribution

  • 00802526613838 ()
7260

  • Patient health record information system application software
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