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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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FLIP Topography Module
Covidien LP
DD-961
In Commercial Distribution

  • 05391530810142 ()


  • Manometric gastrointestinal motility analysis system
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
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- Mini LED Patch to treat mild to moderate acne vulgaris
I-SMART DEVELOPMENTS LIMITED
TN2197
In Commercial Distribution

  • 05060534510685 ()


  • Red/blue light phototherapy unit
Dynamic ECG Systems
Contec Medical Systems Co., Ltd.
TLC5000
In Commercial Distribution

  • 06945040100294 ()


  • Electrocardiographic ambulatory recorder
Dynamic ECG Systems
Contec Medical Systems Co., Ltd.
TLC5007
In Commercial Distribution

  • 06945040101499 ()


  • Electrocardiographic ambulatory recorder
Dynamic ECG Systems
Contec Medical Systems Co., Ltd.
TLC6000
In Commercial Distribution

  • 06945040101406 ()


  • Electrocardiographic ambulatory recorder
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-032908-00
In Commercial Distribution

  • 06944904086415 ()


  • Patient monitoring system module, printing
Medical Grade Tablet with 11.6 inch screen is used with the ORLocate Sponge Solution System.
STERIS CORPORATION
ORLocate Tablet
In Commercial Distribution

OX216

  • Electronic surgical sponge-counter
Medical Grade Tablet with 11.6 inch screen is used with the ORLocate Sponge Solution System.
Steris Corporation
ORLocate Tablet
Not in Commercial Distribution

  • 00724995220679 ()
OX216

  • Electronic surgical sponge-counter
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