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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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8ch Vector Vol. SinUse Man
Covidien LP
9012P1312
Not in Commercial Distribution

  • 05704736001267 ()
  • 10884521742789 ()
9012P1312

  • Manometric gastrointestinal motility analysis system
4ch Anorectal SinUse Man.cath,0,1,2,3-ba
Covidien LP
9012P1302
Not in Commercial Distribution

  • 05704736001250 ()
  • 10884521742772 ()
9012P1302

  • Manometric gastrointestinal motility analysis system
8ch Esophageal Sinuse Ma,
Covidien LP
9012P1212
Not in Commercial Distribution

  • 05704736001243 ()
  • 10884521742758 ()
9012P1212

  • Manometric gastrointestinal motility analysis system
8ch Esophageal Sinuse Ma,
Covidien LP
9012P1222
Not in Commercial Distribution

  • 05704736001236 ()
  • 10884521742765 ()


  • Manometric gastrointestinal motility analysis system
Esophageal SinUse Man. Cath.,0,5,10,15 c
Covidien LP
9012P1202
Not in Commercial Distribution

  • 05704736001229 ()
  • 15704736001226 ()


  • Manometric gastrointestinal motility analysis system
TelePatch CM PM700 is a small, auto triggered, or patient activated, device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
MEDICOMP, INC.
PM700
Not in Commercial Distribution

  • 00862887000371 ()


  • Electrocardiographic ambulatory recorder
Decipher Holter Monitor is a small, patient worn device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
MEDICOMP, INC.
PM461
Not in Commercial Distribution

  • 00862887000364 ()


  • Electrocardiographic ambulatory recorder
Cardiac Monitor PM500 is a small, auto triggered, or patient activated, device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
MEDICOMP, INC.
PM500
Not in Commercial Distribution

  • 00862887000357 ()


  • Electrocardiographic ambulatory recorder
CardioPAL SAVI is a small, patient worn device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
MEDICOMP, INC.
PM410
Not in Commercial Distribution

  • 00862887000340 ()


  • Electrocardiographic ambulatory recorder
Messenger 5.18 Software Release
SPOK INC.
5.18.0
In Commercial Distribution

  • 00865190000304 ()


  • Alarm application software
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