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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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BioOptico Spectral Mode Key Kit
ARTHREX, INC.
AR-3200-1026
In Commercial Distribution

  • 00888867387928 ()
AR-3200-1026

  • Medical image management system
Electrocardiographic telemetry monitoring system transmitter
MORTARA INSTRUMENT, INC.
S4-P-B
Not in Commercial Distribution

  • 00812345024661 ()


  • Centralized patient monitor
Handpiece Tracker (HPT)
Claronav Inc
955-ND-HPTG-000
In Commercial Distribution

  • 07540209955952 ()
955-ND-HPTG-000

  • Surgical planning/navigation-enhancement system
Calibrator
Claronav Inc
950-ND-CAL
In Commercial Distribution

  • 07540209955938 ()
950-ND-CAL

  • Surgical planning/navigation-enhancement system
Navident Training Kit for use with the Navident system
Claronav Inc
955-ND-NVTK
In Commercial Distribution

  • 07540209955044 ()


  • Surgical planning/navigation-enhancement system
Navident accessory kit for use with Navident System
Claronav Inc
955-ND-ACCK
In Commercial Distribution

  • 07540209955037 ()


  • Surgical planning/navigation-enhancement system
Navident Surgical Navigation System - Packaged System (including kits/accessories)
Claronav Inc
955-ND-ND, plus kits
In Commercial Distribution

  • 07540209955006 ()


  • Surgical planning/navigation-enhancement system
No Description
ICU MEDICAL, INC.
WW1100
In Commercial Distribution

  • 35019517062667 ()
  • 15019517062663 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
ICU MEDICAL, INC.
WW1131
In Commercial Distribution

  • 35019517062247 ()
  • 15019517062243 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
ICU MEDICAL, INC.
WW1130
In Commercial Distribution

  • 35019517062230 ()
  • 15019517062236 ()


  • Multiple vital physiological parameter monitoring system, clinical
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