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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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mcompass Anorectal Manometry System - 00851607003051

Medspira mcompass Diagnostic Anorectal Manometry system
MEDSPIRA, LLC
RMD-001
In Commercial Distribution

  • 10851607003058 ()
  • 00851607003051 ()
RMD-001

  • Manometric gastrointestinal motility analysis system

mcompass Anorectal Manometry FOB - 00851607003044

Medspira mcompass Anorectal Manometry FOB
MEDSPIRA, LLC
RMD-001-001
In Commercial Distribution

  • 00851607003044 ()
  • 10851607003041 ()
RMD-001-001

  • Manometric gastrointestinal motility analysis system

QuikLinq FOB Adapter - 00851607003006

Adapter for QuikLinq FOB
MEDSPIRA, LLC
RMD-210-020
In Commercial Distribution

  • 10851607003003 ()
  • 00851607003006 ()


  • Manometric gastrointestinal motility analysis system

ManoScan - 05704736001328

SUM 8ch radial w/balloon,
Covidien LP
9012P1422
Not in Commercial Distribution

  • 05704736001328 ()
  • 10884521742826 ()
9012P1422

  • Manometric gastrointestinal motility analysis system

ManoScan - 05704736001311

8ch Anorectal SUM 0,0.5
Covidien LP
9012P1412
Not in Commercial Distribution

  • 05704736001311 ()
  • 10884521742710 ()
9012P1412

  • Manometric gastrointestinal motility analysis system

ManoScan - 05704736001304

4 ch Anorectal Cat. Sil. w/Bal,
Covidien LP
9012P1392
Not in Commercial Distribution

  • 05704736001304 ()
  • 10884521742703 ()
9012P1392

  • Manometric gastrointestinal motility analysis system

ManoScan - 05704736001298

Single use Catheter 4 ch w/o central lum
Covidien LP
9012P1362
Not in Commercial Distribution

  • 05704736001298 ()
  • 10884521742819 ()
9012P1362

  • Manometric gastrointestinal motility analysis system

ManoScan - 05704736001281

4ch 7.5mm sp Esophageal
Covidien LP
9012P1352
Not in Commercial Distribution

  • 05704736001281 ()
  • 10884521742802 ()
9012P1352

  • Manometric gastrointestinal motility analysis system

ManoScan - 05704736001274

8ch Anorectal SinUse Man,
Covidien LP
9012P1322
Not in Commercial Distribution

  • 05704736001274 ()
  • 10884521742796 ()
9012P1322

  • Manometric gastrointestinal motility analysis system

ManoScan - 05704736001267

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

  • 05704736001267 ()
  • 10884521742789 ()
9012P1312

  • Manometric gastrointestinal motility analysis system
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