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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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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
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
MSS-4581-3D MANOSHIELD 3DAR - BOX 10
Given Imaging, Inc.
MSS-4581-3D
In Commercial Distribution

  • 04260167483719 ()
  • 10884521768062 ()


  • Manometric gastrointestinal motility analysis system
ESO Catheter, RFG
Given Imaging, Inc.
RFG-1286-EAN
In Commercial Distribution

  • 04260167483597 ()


  • Manometric gastrointestinal motility analysis system
AR Catheter, Small
Given Imaging, Inc.
RFG-2195
In Commercial Distribution

  • 04260167482545 ()


  • Manometric gastrointestinal motility analysis system
AR 3D Probe
Given Imaging, Inc.
RFG-3885
In Commercial Distribution

  • 04260167482538 ()


  • Manometric gastrointestinal motility analysis system
ESO Catheter, SD Regular
Given Imaging, Inc.
RFG-3887
In Commercial Distribution

  • 04260167482514 ()


  • Manometric gastrointestinal motility analysis system
ESO With Extended Tip
Given Imaging, Inc.
RFG-8000-15
In Commercial Distribution

  • 04260167482491 ()


  • Manometric gastrointestinal motility analysis system
AR Catheter, Regular
Given Imaging, Inc.
2192
In Commercial Distribution

  • 04260167482477 ()


  • Manometric gastrointestinal motility analysis system
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