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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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BD FACSCanto™ II System Software
Becton, Dickinson And Company
664110
In Commercial Distribution

  • 00382906641106 ()
664110

  • Laboratory analyser operation system software IVD
BD FACSCanto II System Software V2.4
BECTON, DICKINSON AND COMPANY
646601
Not in Commercial Distribution

  • 00382906466013 ()
646601

  • Laboratory instrument/analyser application software IVD
OARtrac Proprietary System Software for CDU
RADIADYNE, L.L.C.
OT-PSS
In Commercial Distribution

  • 00851546007097 ()
OT-PSS

  • MOSFET radiation therapy dosimetry system
PillCam (TM) Desktop Software v9.7 Upgrade
Given Imaging, Inc.
FGS-0803
In Commercial Distribution

  • 10884521845923 ()


  • Video capsule endoscopy system application software
Software Version 1.3 for Aurora Xi
Fresenius Kabi AG
1.3
In Commercial Distribution

  • 00810020440898 ()


  • Apheresis system
Aurora Plasmapheresis System Software Version 2.1
Fresenius Kabi AG
SW 2.1
In Commercial Distribution

  • 00810020440003 ()
  • 10810020440000 ()


  • Apheresis system
Siemens UNITY 3 SOFTWARE (USB STICK)
Ws Audiology Usa, Inc.
UNITY 3 SOFTWARE (USB STICK)
Not in Commercial Distribution

  • 04046355641976 ()
10823966

  • Audiometric/hearing aid tester
Site~Rite 8 Software v. 3.0.1
Bard Access Systems, Inc.
SR8v3.0.1
In Commercial Distribution

  • 00801741225895 ()
SR8v3.0.1

  • General-purpose ultrasound imaging system
Site~Rite 8 Sherlock Application Software
Bard Access Systems, Inc.
Sherlockv3.1.1
In Commercial Distribution

  • 00801741219436 ()
Sherlockv3.1.1

  • Central venous catheter navigation system, electrocardiographic/magnetic
Site~Rite 8 Software v. 2.3.1
Bard Access Systems, Inc.
SR8v2.3.1
In Commercial Distribution

  • 00801741219382 ()
SR8v2.3.1

  • General-purpose ultrasound imaging system
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