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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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Jaw Tracker B
Claronav Inc
955-ND-JTVB
In Commercial Distribution

  • 07540209955778 ()
955-ND-JTVB

  • Surgical planning/navigation-enhancement system
Tracer 3
Claronav Inc
955-ND-TRTO (Version 3)
In Commercial Distribution

  • 07540209955761 ()
955-ND-TRTO

  • Surgical planning/navigation-enhancement system
Monitor with Nellcor SPO2, NIBP, HR, Temp, and Printer
CRITICARE TECHNOLOGIES, INC.
VitalCare 506LNVP3
In Commercial Distribution

  • B438506LNVP30 ()


  • Multiple vital physiological parameter monitoring system, clinical
Monitor with Nellcor SPO2, NIBP, HR, and Printer
CRITICARE TECHNOLOGIES, INC.
VitalCare 506LNP3
In Commercial Distribution

  • B438506LNP30 ()


  • Multiple vital physiological parameter monitoring system, clinical
Wireless Patient Monitor
ATHENA GTX, INC.
WVSM RWC + miniCap
In Commercial Distribution

  • B3945000034040 ()
500-0034-04

  • Multiple vital physiological parameter monitoring system, clinical
Wireless Patient Monitor
ATHENA GTX, INC.
WVSM RWC + miniCap
In Commercial Distribution

  • B3945000034030 ()
500-0034-03

  • Multiple vital physiological parameter monitoring system, clinical
Wireless Patient Monitor
ATHENA GTX, INC.
WVSM RWC + miniCap
In Commercial Distribution

  • B3945000034020 ()
500-0034-02

  • Multiple vital physiological parameter monitoring system, clinical
Wireless Patient Monitor
ATHENA GTX, INC.
WVSM RWC + miniCap
In Commercial Distribution

  • B3945000034010 ()
500-0034-01

  • Multiple vital physiological parameter monitoring system, clinical
Athena GTX Device Management Suite - Android
ATHENA GTX, INC.
ADMS Android Software
In Commercial Distribution

  • B3943950010000 ()
395-0010-00

  • Centralized patient monitor
Athena GTX Device Management Suite - iOS
ATHENA GTX, INC.
ADMS iOS Software
In Commercial Distribution

  • B3943950009000 ()
395-0009-00

  • Centralized patient monitor
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