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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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The FFRangio™ System, manufactured by CathWorks Ltd., is a non-invasive image-‎based software ‎device that provides physicians with a quantitative analysis of ‎functional significance of a coronary ‎lesion, similar to invasive FFR (Fractional Flow ‎Reserve), and a qualitative three-dimensional model of ‎the demonstrated coronary ‎arteries, during routine PCI procedure. The FFRangio™ System performs ‎all required ‎processing and calculations based only on angiography images and hemodynamics ‎‎information that are acquired during the coronary catheterization procedure.‎
CATHWORKS LTD
FAU01000
In Commercial Distribution

  • 17290017855025 ()
  • 07290017855028 ()
FAU01000

  • Diagnostic x-ray digital imaging system workstation
LessRay Extension, Table Array
Nuvasive, Inc.
8230042
In Commercial Distribution

  • 00887517976062 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Monitor & Bracket, 15.6" Touch
Nuvasive, Inc.
8230007
In Commercial Distribution

  • 00887517732729 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Monitor and Bracket, 27"
Nuvasive, Inc.
8230006
In Commercial Distribution

  • 00887517732712 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Computer Enclosure
Nuvasive, Inc.
8230004
In Commercial Distribution

  • 00887517732699 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Cart
Nuvasive, Inc.
8230002
In Commercial Distribution

  • 00887517732675 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Remote, Wired
Nuvasive, Inc.
8230022
In Commercial Distribution

  • 00887517805997 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Radix Lens', 40 Pack
Nuvasive, Inc.
8230019
In Commercial Distribution

  • 00887517756787 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Case, 12" C-Arm Collar
Nuvasive, Inc.
8230018
In Commercial Distribution

  • 00887517756770 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Articulating Arm, Camera
Nuvasive, Inc.
8230017
In Commercial Distribution

  • 00887517756763 ()


  • Diagnostic x-ray digital imaging system workstation
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