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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.
H12PLUS-AHD-XXXXX
Not in Commercial Distribution

  • 00817655022208 ()


  • Electrocardiographic ambulatory recorder
Holter Recorder
MORTARA INSTRUMENT, INC.
H3PLUS-COA-XXXXX
In Commercial Distribution

  • 00817655022192 ()


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

  • 00817655022086 ()


  • Electrocardiographic ambulatory recorder
H3+ 3-channel digital Holter Recorder - 7-day, includes carry case with clip, and hookup kit (not available for US); Multiple languages and CD manual (except Brazilian Portuguese); IEC 5 wire, 15 inch (38cm), LeadForm patient cable with snap ends
WELCH ALLYN, INC.
901142
In Commercial Distribution

  • 00817655020853 ()
H3PLUS-CAE-XXXXX

  • 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
LessRay Extension, Table Array
Nuvasive, Inc.
8230042
In Commercial Distribution

  • 00887517976062 ()


  • Diagnostic x-ray digital imaging system workstation
LessRay CE Table Array Set
Nuvasive, Inc.
LRTABLELOANCE
In Commercial Distribution

  • 00887517996022 ()


  • Diagnostic x-ray digital imaging system workstation
Lessray Touchscreen Monitor
Nuvasive, Inc.
8230044
In Commercial Distribution

  • 00887517994813 ()


  • Diagnostic x-ray digital imaging system workstation
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