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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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NeuroWorks TrexHD Monitoring Software Installation Media (US)
XLTEK
021764
In Commercial Distribution

  • 00382830043380 ()


  • Electroencephalograph
EMG Software Upgrade with New System Order
NATUS NEUROLOGY INCORPORATED
017806
In Commercial Distribution

  • 00382830061933 ()


  • Electromyograph
BD FACSCount System Users Guide and Software
Becton, Dickinson And Company
344619
In Commercial Distribution

  • 00382903446193 ()
344619

  • Laboratory instrument/analyser application software IVD
Natus Elite - Synergy & Viking Combo Master Software
NATUS NEUROLOGY INCORPORATED
828-069500
In Commercial Distribution

  • 00382830035019 ()


  • Electromyograph
Aurora Xi Plasmapheresis System Software Version 1.2
Fresenius Kabi AG
1.2
In Commercial Distribution

  • 04086000101967 ()


  • Apheresis system
Abbott Diabetes Care USB Data Cable Software
ABBOTT DIABETES CARE INC
70845
In Commercial Distribution

  • 30093815708453 ()
  • 00093815708452 ()
  • 00093815000839 ()
70845

  • Electrical-only medical device connection cable, reusable
Abbott Diabetes Care USB Data Cable Software
ABBOTT DIABETES CARE INC
70845
Not in Commercial Distribution

  • 30093815000830 ()
  • 00093815000839 ()
  • 57599-0845-1 ()
70845

  • Electrical-only medical device connection cable, reusable
PillCam™ Software v9.0 for WS, USA
Given Imaging, Inc.
FGS-0637
In Commercial Distribution

  • 07290110360191 ()


  • Video capsule endoscopy system application software
Site~Rite 9 Ultrasound Software v.1.2.0
Bard Access Systems, Inc.
SR9v1.2.0
In Commercial Distribution

  • 00801741231186 ()
SR9v1.2.0

  • Central venous catheter navigation system, electrocardiographic/magnetic
  • General-purpose ultrasound imaging system
Site Rite 8 Ultrasound System Application Software
Bard Access Systems, Inc.
SR8v2.4.0
In Commercial Distribution

  • 00801741219405 ()
SR8v2.4.0

  • General-purpose ultrasound imaging system
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