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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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Switch, Inline Flow Control, Female Luer Inlet, Male Luer Outlet, 5-pack - 00851607003143

No Description
MEDSPIRA, LLC
RMD-010-001
In Commercial Distribution

  • 00851607003143 ()


  • Manometric gastrointestinal motility analysis system

Pouch with Strap for mcompass® FOB - 00851607003099

No Description
MEDSPIRA, LLC
RMD-002-POUCH
In Commercial Distribution

  • 00851607003099 ()
  • 10851607003096 ()


  • Manometric gastrointestinal motility analysis system

mcompass Biofeedback Manometry System - 00851607003068

Medspira Biofeedback Anorectal Manometry System
MEDSPIRA, LLC
RMD-002
In Commercial Distribution

  • 10851607003065 ()
  • 00851607003068 ()
RMD-002

  • Manometric gastrointestinal motility analysis system

mcompass Anorectal Manometry System - 00851607003051

Medspira mcompass Diagnostic Anorectal Manometry system
MEDSPIRA, LLC
RMD-001
In Commercial Distribution

  • 10851607003058 ()
  • 00851607003051 ()
RMD-001

  • Manometric gastrointestinal motility analysis system

mcompass Anorectal Manometry FOB - 00851607003044

Medspira mcompass Anorectal Manometry FOB
MEDSPIRA, LLC
RMD-001-001
In Commercial Distribution

  • 00851607003044 ()
  • 10851607003041 ()
RMD-001-001

  • Manometric gastrointestinal motility analysis system

QuikLinq FOB Adapter - 00851607003006

Adapter for QuikLinq FOB
MEDSPIRA, LLC
RMD-210-020
In Commercial Distribution

  • 10851607003003 ()
  • 00851607003006 ()


  • Manometric gastrointestinal motility analysis system

EndoFLIP - 05391530810142

FLIP Topography Module
Covidien LP
DD-961
In Commercial Distribution

  • 05391530810142 ()


  • Manometric gastrointestinal motility analysis system

Omnilux Blemish Eraser - 05060534510807

Omnilux Blemish Eraser- Mini LED Patch to treat mild to moderate acne vulgaris
I-SMART DEVELOPMENTS LIMITED
TN2197
In Commercial Distribution

  • 05060534510807 ()


  • Red/blue light phototherapy unit

Luma Blemish - 05060534510685

Luma Blemish- Mini LED Patch to treat mild to moderate acne vulgaris
I-SMART DEVELOPMENTS LIMITED
TN2197
In Commercial Distribution

  • 05060534510685 ()


  • Red/blue light phototherapy unit

Omnilux CLEAR - 05060534510234

Over-The-Counter Powered Light Based Laser For Acne- Omnilux CLEAR branded
I-SMART DEVELOPMENTS LIMITED
TN2112
In Commercial Distribution

  • 05060534510234 ()
135-OC

  • Red/blue light phototherapy unit
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