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

  • 00812345027105 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
MORTARA INSTRUMENT, INC.
H12PLUS-AAC-XXXXX
Not in Commercial Distribution

  • 00812345027099 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
MORTARA INSTRUMENT, INC.
BURH3PR
In Commercial Distribution

  • 00812345027044 ()


  • Electrocardiographic ambulatory recorder
H3R Holster (Rev A)
Tz Medical, Inc.
H3R-0027
In Commercial Distribution

  • 00811331013931 ()


  • Electrocardiographic ambulatory recorder
H3R USB Cable
Tz Medical, Inc.
H3R-0025
In Commercial Distribution

  • 00811331013917 ()


  • Electrocardiographic ambulatory recorder
Trident™ 40 3-Electrode Cable
Tz Medical, Inc.
H3R-0017
In Commercial Distribution

  • 00811331013887 ()


  • Electrocardiographic ambulatory recorder
inSIGHT Ultima® System No Workstation No Monitor Int.
DIVERSATEK HEALTHCARE, INC.
ULT1-S-IA
In Commercial Distribution

  • B019ULT1SIA0 ()
ULT1-S-IA

  • Manometric gastrointestinal motility analysis system
inSIGHT Ultima® System No Workstation
DIVERSATEK HEALTHCARE, INC.
ULT1-S-I
In Commercial Distribution

  • B019ULT1SI0 ()
ULT1-S-I

  • Manometric gastrointestinal motility analysis system
inSIGHT Ultima® Base System
DIVERSATEK HEALTHCARE, INC.
ULT1-S
In Commercial Distribution

  • B019ULT1S0 ()
ULT1-S

  • Manometric gastrointestinal motility analysis system
inSIGHT Ultima® HRiM SD System Int.
DIVERSATEK HEALTHCARE, INC.
ULT1-HSD-I
In Commercial Distribution

  • B019ULT1HSDI0 ()
ULT1-HSD-I

  • Manometric gastrointestinal motility analysis system
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