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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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inSIGHT Ultima® HRM System
DIVERSATEK HEALTHCARE, INC.
ULT1-HP-D
In Commercial Distribution

  • B019ULT1HPD0 ()
ULT1-HP-D

  • Manometric gastrointestinal motility analysis system
InSIGHT Ultima® HRiM2 System Int.
DIVERSATEK HEALTHCARE, INC.
ULT1-H-I
In Commercial Distribution

  • B019ULT1HI0 ()
ULT1-H-I

  • Manometric gastrointestinal motility analysis system
inSIGHT Ultima® HRCA System, Int.
DIVERSATEK HEALTHCARE, INC.
ULT1-HCA-D
In Commercial Distribution

  • B019ULT1HCAD0 ()
ULT1-HCA-D

  • Manometric gastrointestinal motility analysis system
inSIGHT Legacy Adaptor Cable
DIVERSATEK HEALTHCARE, INC.
H12R-4500-30
In Commercial Distribution

  • B019H12R4500300 ()
H12R-4500-30

  • Manometric gastrointestinal motility analysis system
No Description
BRAEMAR MANUFACTURING, LLC
100-0046-02
In Commercial Distribution

  • B146M10 ()


  • Electrocardiographic ambulatory recorder
No Description
BRAEMAR MANUFACTURING, LLC
900-0612-04
In Commercial Distribution

  • B146ERWCD040 ()


  • Electrocardiographic ambulatory recorder
No Description
BRAEMAR MANUFACTURING, LLC
900-0570-25
In Commercial Distribution

  • B146DL9ZW0 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0543-11
In Commercial Distribution

  • B146DL8CL0 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0543-19
In Commercial Distribution

  • B146DL8BD0 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0543-04
In Commercial Distribution

  • B146DL8B1330 ()


  • Electrocardiographic ambulatory recorder
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