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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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MiVu - 00816734023143

MiVu Esophageal Endo Cap
DIVERSATEK HEALTHCARE, INC.
MI-ESO-CAP-3L
In Commercial Distribution

  • 00816734023143 ()
MI-ESO-CAP-3L

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - 00816734023112

inSIGHT Ultima Base System
DIVERSATEK HEALTHCARE, INC.
ULTSYS-II
In Commercial Distribution

  • 00816734023112 ()
ULTSYS-II

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - 00816734023105

inSIGHT Ultima Base Cart System
DIVERSATEK HEALTHCARE, INC.
ULTCART-II
In Commercial Distribution

  • 00816734023105 ()
ULTCART-II

  • Manometric gastrointestinal motility analysis system

PriZm - 00816734023099

PriZm Base System
DIVERSATEK HEALTHCARE, INC.
PRIZMSYS-II
In Commercial Distribution

  • 00816734023099 ()
PRIZMSYS-II

  • Manometric gastrointestinal motility analysis system

PriZm - 00816734023082

PriZm Upgrade Kit
DIVERSATEK HEALTHCARE, INC.
PRIZM-KIT-II
In Commercial Distribution

  • 00816734023082 ()
PRIZM-KIT-II

  • Manometric gastrointestinal motility analysis system

PriZm - 00816734023075

PriZm Base Cart System
DIVERSATEK HEALTHCARE, INC.
PRIZMCART-II
In Commercial Distribution

  • 00816734023075 ()
PRIZMCART-II

  • Manometric gastrointestinal motility analysis system

PriZm - 00816734023068

PriZm® Central Unit
DIVERSATEK HEALTHCARE, INC.
H20-4500
In Commercial Distribution

  • 00816734023068 ()
H20-4500

  • Manometric gastrointestinal motility analysis system

Ultima - 00816734023013

Ultima Cable for HRCA Manometry Probe (Lemo Connector)
DIVERSATEK HEALTHCARE, INC.
H12R-7210
In Commercial Distribution

  • 00816734023013 ()
H12R-7210

  • Manometric gastrointestinal motility analysis system

Ultima - 00816734023006

Ultima Cable for High Resolution Manometry Probe
DIVERSATEK HEALTHCARE, INC.
H12R-7110
In Commercial Distribution

  • 00816734023006 ()
H12R-7110

  • Manometric gastrointestinal motility analysis system

PriZm - 00816734022993

PriZm® Central Unit
DIVERSATEK HEALTHCARE, INC.
H20-4000
In Commercial Distribution

  • 00816734022993 ()
H20-4000

  • Manometric gastrointestinal motility analysis system
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