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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LessRay Case, 9" C-Arm Collar
Nuvasive, Inc.
8230013
In Commercial Distribution

  • 00887517756725 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Bed Post
Nuvasive, Inc.
8230012
In Commercial Distribution

  • 00887517756718 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Array, Bed
Nuvasive, Inc.
8230011
In Commercial Distribution

  • 00887517756701 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Array, Right
Nuvasive, Inc.
8230010
In Commercial Distribution

  • 00887517756695 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay Array, Left
Nuvasive, Inc.
8230009
In Commercial Distribution

  • 00887517756688 ()


  • Diagnostic x-ray digital imaging system workstation
The FFRangio System is a non invasive image based software device
CATHWORKS LTD
FAU04000
In Commercial Distribution

  • 17290017855056 ()
  • 07290017855059 ()
FAU04000

  • Diagnostic x-ray digital imaging system workstation
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
ProTube is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. ProTube is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers, sample check-out and monitoring of transport parameters.
Inpeco SA
PTB
In Commercial Distribution

  • 07640172343012 ()


  • Specimen information management system IVD
The ProTube System is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. The ProTube System is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers and sample check-out.
Inpeco SA
PTB
In Commercial Distribution

  • 07640172343005 ()


  • Specimen information management system IVD
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
set of 6 models Head support regular density extra soft (for Push Pin Hardware)
Orfit Industries NV
32450
In Commercial Distribution

  • 05420028702079 ()


  • DNA-based tissue typing IVD, reagent
32" Shelf with stainless steel top for XM, VBM, CM carriers, includes mounting hardware
SKYTRON LLC
3XMSHSS
In Commercial Distribution

  • 10841736113988 ()


  • General utility supply system, ceiling-mounted
22" Shelf with stainless steel top for PM, VBM, CM carriers, includes mounting hardware
SKYTRON LLC
3PMSHSS
In Commercial Distribution

  • 10841736113919 ()


  • General utility supply system, ceiling-mounted
16.5" Shelf with stainless steel top for KM, VBM, CM carriers, includes mounting hardware
SKYTRON LLC
3KMSHSS
In Commercial Distribution

  • 10841736113889 ()


  • General utility supply system, ceiling-mounted
Accessory Box single level, w/hardware (2 screws & nuts) 1.5" x 3.5" x 1"
Avalign Technologies, Inc.
95-2000100036
In Commercial Distribution

  • 00190776121471 ()


  • Device sterilization/disinfection container, reusable
4 x 5 Lateral Pads, Curved with S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368993 ()

  • Width: 5 Inch
  • Length: 4 Inch
PLLSC4x5BR

  • Wheelchair head/trunk support, prefabricated
4 x 5 Lateral Pads, Flat with S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368979 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLS4x5BR

  • Wheelchair head/trunk support, prefabricated
4 x 5 Lateral Pads, Flat with Fixed Modular Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368955 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLFM4x5BR

  • Wheelchair head/trunk support, prefabricated
3 x 4 Lateral Pads, Curved with S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368887 ()

  • Length: 3 Inch
  • Width: 4 Inch
PLLSC3x4BL

  • Wheelchair head/trunk support, prefabricated
4 x 5 Lateral Pads, Flat with Fixed Modular Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368856 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLFM4x5BL

  • Wheelchair head/trunk support, prefabricated
4 x 5 Lateral Pads, Curved with S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368795 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLSC4x5BR

  • Wheelchair head/trunk support, prefabricated
3 x 4 Lateral Pads, Curved with S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368788 ()

  • Length: 3 Inch
  • Width: 4 Inch
PBLSC3x4BR

  • Wheelchair head/trunk support, prefabricated
4 x 5 Lateral Pads, Flat with S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368771 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLS4x5BR

  • Wheelchair head/trunk support, prefabricated
3 x 4 Lateral Pads, Flat with S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368764 ()

  • Width: 4 Inch
  • Length: 3 Inch
PBLS3x4BR

  • Wheelchair head/trunk support, prefabricated
4 x 5 Lateral Pads, Flat with Fixed Modular Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368757 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLFM4x5BR

  • Wheelchair head/trunk support, prefabricated
3 x 4 Lateral Pads, Flat with Fixed Modular Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368740 ()

  • Length: 3 Inch
  • Width: 4 Inch
PBLFM3x4BR

  • Wheelchair head/trunk support, prefabricated
4 x 5 Lateral Pads, Curved with S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368696 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLSC4x5BL

  • Wheelchair head/trunk support, prefabricated
3 x 4 Lateral Pads, Curved with S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368689 ()

  • Width: 4 Inch
  • Length: 3 Inch
PBLSC3x4BL

  • Wheelchair head/trunk support, prefabricated
4 x 5 Lateral Pads, Flat with S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368672 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLS4x5BL

  • Wheelchair head/trunk support, prefabricated
3 x 4 Lateral Pads, Flat with S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368665 ()

  • Width: 4 Inch
  • Length: 3 Inch
PBLS3x4BL

  • Wheelchair head/trunk support, prefabricated
4 x 5 Lateral Pads, Flat with Fixed Modular Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368658 ()

  • Width: 5 Inch
  • Length: 4 Inch
PBLFM4x5BL

  • Wheelchair head/trunk support, prefabricated
3 x 4 Lateral Pads, Flat with Fixed Modular Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368641 ()

  • Width: 4 Inch
  • Length: 3 Inch
PBLFM3x4BL

  • Wheelchair head/trunk support, prefabricated
4 x 5 Lateral Pelvic Pads with Swing Away Mounting Hardware (Right) (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367637 ()

  • Width: 5 Inch
  • Length: 4 Inch
PLASP4x5PR

  • Wheelchair head/trunk support, prefabricated
3 x 4 Lateral Pelvic Pads with Swing Away Mounting Hardware (Right) (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367620 ()

  • Width: 4 Inch
  • Length: 3 Inch
PLASP3x4PR

  • Wheelchair head/trunk support, prefabricated
4 x 5 Lateral Pelvic Pads with Swing Away Mounting Hardware (Left) (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367590 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLASP4x5PL

  • Wheelchair head/trunk support, prefabricated
3 x 4 Lateral Pelvic Pads with Swing Away Mounting Hardware (Left) (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367583 ()

  • Length: 3 Inch
  • Width: 4 Inch
PLASP3x4PL

  • Wheelchair head/trunk support, prefabricated
4 x 5 Lateral Pelvic Pads with Swing Away Mounting Hardware (Pair) (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363367552 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLASP4x5PP

  • Wheelchair head/trunk support, prefabricated
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