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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.
11111-002-50    
In Commercial Distribution

  • 00817655020242 ()


  • Cardiology information system application software
TrueFit Software v5.4
Sonova AG
058-5178-054
In Commercial Distribution

  • 07613389644579 ()
058-5178-054

  • Audiometric/hearing device software
Clarity® Software
Elekta Solutions AB
9310-00044
In Commercial Distribution

  • 07540180000221 ()


  • Ultrasound patient positioning system
Clarity® Software
Elekta Ltd
9310-00043
In Commercial Distribution

  • 07540180000207 ()


  • Ultrasound patient positioning system
FLUOROMAP 1.0 SOFTWARE
Stryker Leibinger GmbH & Co. KG
6006-600-000
In Commercial Distribution

  • 07613252286578 ()
6006-600-000

  • Robotic surgical navigation system application software
TL-HEX APPLICATION SOFTWARE
ORTHOFIX SRL
01
In Commercial Distribution

  • 18054242511847 ()
TLHEXSW

  • External orthopaedic fixation frame calculation software
Navios Analysis Software
BECKMAN COULTER IRELAND INC.
774953
In Commercial Distribution

  • 15099590512453 ()
774953

  • Laboratory instrument/analyser application software IVD
Navios Analysis Software
BECKMAN COULTER IRELAND INC.
774951
In Commercial Distribution

  • 15099590512125 ()
774951

  • Laboratory instrument/analyser application software IVD
Navios Analysis Software
BECKMAN COULTER IRELAND INC.
774952
In Commercial Distribution

  • 15099590512118 ()
774952

  • Laboratory instrument/analyser application software IVD
Navios tetra Software
BECKMAN COULTER IRELAND INC.
775213
In Commercial Distribution

  • 15099590510756 ()
775213

  • Laboratory instrument/analyser application software IVD
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