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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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N/A - 04961333229932

Manometry Sensors (Gaeltec)
PENTAX OF AMERICA, INC.
7123
In Commercial Distribution

  • 04961333229932 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333229925

EMG Transducers (two channel)
PENTAX OF AMERICA, INC.
7122
In Commercial Distribution

  • 04961333229925 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333230495

Tongue Arrays
PENTAX OF AMERICA, INC.
7183-4500
In Commercial Distribution

  • 04961333230495 ()
  • 34961333230496 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333230464

Tongue Arrays
PENTAX OF AMERICA, INC.
7179-0040
In Commercial Distribution

  • 04961333230464 ()
  • 34961333230465 ()


  • Manometric gastrointestinal motility analysis system

n/a - 04961333230457

Tongue Arrays
PENTAX OF AMERICA, INC.
7179-0035
In Commercial Distribution

  • 04961333230457 ()
  • 34961333230458 ()


  • Manometric gastrointestinal motility analysis system

n/a - 04961333230440

Nasal Cannulas
PENTAX OF AMERICA, INC.
7179-0030
In Commercial Distribution

  • 04961333230440 ()
  • 14961333230446 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333230433

Electrodes
PENTAX OF AMERICA, INC.
7179-0025
In Commercial Distribution

  • 04961333230433 ()
  • 14961333230439 ()


  • Manometric gastrointestinal motility analysis system

N/A - 04961333230426

Electrodes
PENTAX OF AMERICA, INC.
7179-0020
In Commercial Distribution

  • 04961333230426 ()
  • 14961333230422 ()


  • Manometric gastrointestinal motility analysis system

Microlife - 04719003315085

WBP Home A BT (BP3MX1-3C) with Universal Label for USA/EU/CA markets
MICROLIFE USA, INC.
CRO-BP3MX1-3C1
In Commercial Distribution

  • 04719003315085 ()
  • 14719003315082 ()
  • 24719003315089 ()
  • 34719003315086 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 04719003315030

WatchBP O3 2G(BP3SZ1-1) Advanced type
MICROLIFE USA, INC.
BP3SZ1-1
In Commercial Distribution

  • 14719003315037 ()
  • 04719003315030 ()
  • 24719003315034 ()
WatchBP O3 2G

  • Arrythmia-detection blood pressure ambulatory recorder
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