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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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Air Charged Adapter Cable
DIVERSATEK HEALTHCARE, INC.
GIS-7010
In Commercial Distribution

  • 00816734021828 ()
GIS-7010

  • Manometric gastrointestinal motility analysis system
Anorectal Balloon
DIVERSATEK HEALTHCARE, INC.
A86-1070
In Commercial Distribution

  • 10816734021689 ()
  • 00816734021682 ()
  • B019A8610700 ()
A86-1070

  • Manometric gastrointestinal motility analysis system
Sphincter Locator
DIVERSATEK HEALTHCARE, INC.
A04-2000-S
In Commercial Distribution

  • 00816734021675 ()
  • B019A042000S0 ()
A04-2000-S

  • Manometric gastrointestinal motility analysis system
Sphincter Locator
DIVERSATEK HEALTHCARE, INC.
A04R-2500
In Commercial Distribution

  • 00816734021668 ()
  • B019A04R25000 ()
A04R-2500

  • Manometric gastrointestinal motility analysis system
HRaM Syringe/Stopcock Kit
DIVERSATEK HEALTHCARE, INC.
A86-4120
In Commercial Distribution

  • 00816734021545 ()
  • B019A8641200 ()
A86-4120

  • Manometric gastrointestinal motility analysis system
Polyurethane Bands (Disk of 20 Bands) for HRaM catheters
DIVERSATEK HEALTHCARE, INC.
A86-4100
In Commercial Distribution

  • 00816734021538 ()
  • B019A8641000 ()
A86-4100

  • Manometric gastrointestinal motility analysis system
HRaM Kit includes 10 anorectal balloons, 20 polyurethane bands, and a suture removal kit
DIVERSATEK HEALTHCARE, INC.
A86-4110-10
In Commercial Distribution

  • 00816734021514 ()
  • B019A864110100 ()
A86-4110-10

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

  • 00816734023457 ()
HRIMSD-KIT

  • Manometric gastrointestinal motility analysis system
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