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

  • 00816734023006 ()
H12R-7110

  • Manometric gastrointestinal motility analysis system
PriZm® Central Unit
DIVERSATEK HEALTHCARE, INC.
H20-4000
In Commercial Distribution

  • 00816734022993 ()
H20-4000

  • Manometric gastrointestinal motility analysis system
PriZm Upgrade Kit for MiVu Mucosal Integrity
DIVERSATEK HEALTHCARE, INC.
PRIZM-KIT
In Commercial Distribution

  • 00816734022948 ()
PRIZM-KIT

  • Manometric gastrointestinal motility analysis system
MiVu Mucosal Integrity Starter Kit
DIVERSATEK HEALTHCARE, INC.
MIVU-KIT
In Commercial Distribution

  • 00816734022931 ()
MIVU-KIT

  • Manometric gastrointestinal motility analysis system
Replacement Cable for Zvu® HRiM and HRaM Probes
DIVERSATEK HEALTHCARE, INC.
H12R-7610
In Commercial Distribution

  • 00816734022894 ()
H12R-7610

  • Manometric gastrointestinal motility analysis system
PriZm Base System
DIVERSATEK HEALTHCARE, INC.
PRIZMSYS
In Commercial Distribution

  • 00816734022887 ()
PRIZMSYS

  • Manometric gastrointestinal motility analysis system
PriZm® Upgrade Kit
DIVERSATEK HEALTHCARE, INC.
PRIZMUPG-KIT
In Commercial Distribution

  • 00816734022610 ()
PRIZMUPG-KIT

  • Manometric gastrointestinal motility analysis system
Z/pH Probe
DIVERSATEK HEALTHCARE, INC.
CZAN-BT-62
In Commercial Distribution

  • 00816734022467 ()
  • B019CZANBT620 ()
CZAN-BT-62

  • Manometric gastrointestinal motility analysis system
Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZPN-BS-50
In Commercial Distribution

  • 00816734022412 ()
  • B019ZPNBS500 ()

  • Catheter Gauge: 6.4 French
ZPN-BS-50

  • Manometric gastrointestinal motility analysis system
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