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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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Holter Recorder
MORTARA INSTRUMENT, INC.
H12PLUS-BAC-XXXXX
Not in Commercial Distribution

  • 00817655020334 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
MORTARA INSTRUMENT, INC.
H12PLUS-GAA-XXXXX
Not in Commercial Distribution

  • 00817655022925 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
MORTARA INSTRUMENT, INC.
H12PLUS-AHD-XXXXX
Not in Commercial Distribution

  • 00817655022208 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
MORTARA INSTRUMENT, INC.
H3PLUS-COA-XXXXX
In Commercial Distribution

  • 00817655022192 ()


  • Electrocardiographic ambulatory recorder
Desktop PC with Zvu Software
DIVERSATEK HEALTHCARE, INC.
COMP-KIT
In Commercial Distribution

  • 00816734023488 ()
COMP-KIT

  • Manometric gastrointestinal motility analysis system
Anal Sphincter Electromyography Kit
DIVERSATEK HEALTHCARE, INC.
EMG-KIT
In Commercial Distribution

  • 00816734023471 ()
EMG-KIT

  • Manometric gastrointestinal motility analysis system
High Resolution Anorectal Manometry Probe Kit
DIVERSATEK HEALTHCARE, INC.
HRAM-KIT
In Commercial Distribution

  • 00816734023464 ()
HRAM-KIT

  • Manometric gastrointestinal motility analysis system
HRiM SD High Resolution Impedance Manometry Probe Kit
DIVERSATEK HEALTHCARE, INC.
HRIMSD-KIT
In Commercial Distribution

  • 00816734023457 ()
HRIMSD-KIT

  • Manometric gastrointestinal motility analysis system
HRiM2 High Resolution Impedance Manometry Probe Kit
DIVERSATEK HEALTHCARE, INC.
HRIM-KIT
In Commercial Distribution

  • 00816734023440 ()
HRIM-KIT

  • Manometric gastrointestinal motility analysis system
Manometry Starter Kit
DIVERSATEK HEALTHCARE, INC.
MANO-KIT
In Commercial Distribution

  • 00816734023433 ()
MANO-KIT

  • Manometric gastrointestinal motility analysis system
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