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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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ManoView - 07290101369578

ManoView ESO Software v3.3
Given Imaging, Inc.
FGS-0628
In Commercial Distribution

  • 07290101369578 ()


  • Manometric gastrointestinal motility analysis system

ManoView - 07290101369059

AR v3.0 Software Upgrade kit
Given Imaging, Inc.
FGS-8031
In Commercial Distribution

  • 07290101369059 ()


  • Manometric gastrointestinal motility analysis system

ManoView - 07290101369042

ESO v3.0.1 SW Upgrade kit
Given Imaging, Inc.
FGS-8029
In Commercial Distribution

  • 07290101369042 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 07290101366973

Assy, ManoScan Cart
Given Imaging, Inc.
FGS-8039
In Commercial Distribution

  • 07290101366973 ()


  • Manometric gastrointestinal motility analysis system

Capillus - 00810045461427

Red and blue light therapy device to reduce the appearance of fine lines and wrinkles and treat mild to moderate acne vulgaris.
CAPILLUS, LLC
AST-804
Not in Commercial Distribution

  • 00810045461427 ()


  • Red/blue light phototherapy unit

H12+ - 00817655020440

Holter Recorder
MORTARA INSTRUMENT, INC.
H12PLUS-HAA-XXXXX
Not in Commercial Distribution

  • 00817655020440 ()


  • Electrocardiographic ambulatory recorder

H3+ - 00817655020433

Holter Recorder
MORTARA INSTRUMENT, INC.
H3PLUS-CAD-XXXXX
In Commercial Distribution

  • 00817655020433 ()


  • Electrocardiographic ambulatory recorder

H12+ - 00817655020334

Holter Recorder
MORTARA INSTRUMENT, INC.
H12PLUS-BAC-XXXXX
Not in Commercial Distribution

  • 00817655020334 ()


  • Electrocardiographic ambulatory recorder

H12+ - 00817655022208

Holter Recorder
MORTARA INSTRUMENT, INC.
H12PLUS-AHD-XXXXX
Not in Commercial Distribution

  • 00817655022208 ()


  • Electrocardiographic ambulatory recorder

H3+ - 00817655022192

Holter Recorder
MORTARA INSTRUMENT, INC.
H3PLUS-COA-XXXXX
In Commercial Distribution

  • 00817655022192 ()


  • Electrocardiographic ambulatory recorder
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