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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Sinuscope 4.0mm, 30
PENTAX OF AMERICA, INC.
8854
In Commercial Distribution

  • 04961333230198 ()

  • Angle: 30 degree
  • Outer Diameter: 4.0 Millimeter


  • Rigid optical nasopharyngoscope
Sinuscope 4.0mm, 0
PENTAX OF AMERICA, INC.
8853
In Commercial Distribution

  • 04961333230181 ()

  • Angle: 0 degree
  • Outer Diameter: 4.0 Millimeter


  • Rigid optical nasopharyngoscope
Sinuscope 2.7mm, 70
PENTAX OF AMERICA, INC.
8852
In Commercial Distribution

  • 04961333230174 ()

  • Angle: 70 degree
  • Outer Diameter: 2.7 Millimeter


  • Rigid optical nasopharyngoscope
Sinuscope 2.7mm, 30
PENTAX OF AMERICA, INC.
8851
In Commercial Distribution

  • 04961333230167 ()

  • Angle: 30 degree
  • Outer Diameter: 2.7 Millimeter


  • Rigid optical nasopharyngoscope
Sinuscope 2.7mm, 0
PENTAX OF AMERICA, INC.
8850
In Commercial Distribution

  • 04961333230150 ()

  • Angle: 0 degree
  • Outer Diameter: 2.7 Millimeter


  • Rigid optical nasopharyngoscope
Sterilization basket, Sinuscope
PENTAX OF AMERICA, INC.
8845
In Commercial Distribution

  • 04961333230143 ()


  • Rigid optical nasopharyngoscope
Pressure Port Tubes, 25 Qty
PENTAX OF AMERICA, INC.
6614
In Commercial Distribution

  • 04961333230136 ()
  • 14961333230133 ()


  • Electroglottograph
PAS Airflow Head-to-Mask Couplers
PENTAX OF AMERICA, INC.
6613
In Commercial Distribution

  • 04961333230129 ()
  • 14961333230126 ()


  • Electroglottograph
PAS Tubes, Pressure Screening
PENTAX OF AMERICA, INC.
6612
In Commercial Distribution

  • 04961333230112 ()
  • 14961333230119 ()


  • Electroglottograph
PAS Tubes, Cardboard
PENTAX OF AMERICA, INC.
6610
In Commercial Distribution

  • 04961333230105 ()
  • 14961333230102 ()


  • Electroglottograph
PAS Pediatric Mask & Adapter (Reusable)
PENTAX OF AMERICA, INC.
6606
In Commercial Distribution

  • 04961333230099 ()


  • Electroglottograph
PAS Mask and Adapter (Reusable)
PENTAX OF AMERICA, INC.
6602
In Commercial Distribution

  • 04961333230082 ()


  • Electroglottograph
PAS Airflow Head
PENTAX OF AMERICA, INC.
6601
In Commercial Distribution

  • 04961333230075 ()


  • Electroglottograph
Speech Products Master Upgrade
PENTAX OF AMERICA, INC.
5298
In Commercial Distribution

  • 04961333230068 ()


  • Electroglottograph
Educational Bundle, Speech Software
PENTAX OF AMERICA, INC.
5157
Not in Commercial Distribution

  • 04961333230051 ()


  • Electroglottograph
Signal Enhancement Program, Software
PENTAX OF AMERICA, INC.
5142
Not in Commercial Distribution

  • 04961333230044 ()


  • Electroglottograph
Computer for Mult-Speech or CSL
PENTAX OF AMERICA, INC.
4307
In Commercial Distribution

  • 04961333230037 ()


  • Electroglottograph
Multi-Speech USB Sound Recorder & Preamp
PENTAX OF AMERICA, INC.
3710
Not in Commercial Distribution

  • 04961333230020 ()


  • Electroglottograph
Games, Software
PENTAX OF AMERICA, INC.
5167B
In Commercial Distribution

  • 04961333229987 ()


  • Electroglottograph
Computerized Speech Lab, H/W & S/W
PENTAX OF AMERICA, INC.
4150B
Not in Commercial Distribution

  • 04961333229970 ()


  • Electroglottograph
Visi-Pitch IV
PENTAX OF AMERICA, INC.
3950B
In Commercial Distribution

  • 04961333229963 ()


  • Electroglottograph
Laryngeal Microphone
PENTAX OF AMERICA, INC.
7126
In Commercial Distribution

  • 04961333229956 ()


  • Manometric gastrointestinal motility analysis system
Nasal Cannulas
PENTAX OF AMERICA, INC.
7125
In Commercial Distribution

  • 04961333229949 ()
  • 14961333229945 ()


  • Manometric gastrointestinal motility analysis system
Manometry Sensors (Gaeltec)
PENTAX OF AMERICA, INC.
7123
In Commercial Distribution

  • 04961333229932 ()


  • Manometric gastrointestinal motility analysis system
EMG Transducers (two channel)
PENTAX OF AMERICA, INC.
7122
In Commercial Distribution

  • 04961333229925 ()


  • Manometric gastrointestinal motility analysis system
PAS Tubes, Intraoral
PENTAX OF AMERICA, INC.
6611
In Commercial Distribution

  • 04961333229918 ()
  • 14961333229915 ()


  • Electroglottograph
Phonatory Aerodynamic System
PENTAX OF AMERICA, INC.
6600
In Commercial Distribution

  • 04961333229901 ()


  • Electroglottograph
Nasometer
PENTAX OF AMERICA, INC.
6450
In Commercial Distribution

  • 04961333229895 ()


  • Electroglottograph
KayPentax Electroglottograph
PENTAX OF AMERICA, INC.
6103
In Commercial Distribution

  • 04961333229888 ()


  • Electroglottograph
Applied Speech Science for Voice & Resonance Disorders, Software
PENTAX OF AMERICA, INC.
5156
Not in Commercial Distribution

  • 04961333229871 ()


  • Electroglottograph
Nueroscience for Human Communication, Software
PENTAX OF AMERICA, INC.
5155
In Commercial Distribution

  • 04961333229864 ()


  • Electroglottograph
Applied Speech Science for Dysarthrias, Software
PENTAX OF AMERICA, INC.
5153
Not in Commercial Distribution

  • 04961333229840 ()


  • Electroglottograph
Respiration, Phonation and Prosody Simulation, Software
PENTAX OF AMERICA, INC.
5152
Not in Commercial Distribution

  • 04961333229833 ()


  • Electroglottograph
Phonetic & Perception Simulation Program, Software
PENTAX OF AMERICA, INC.
5151
Not in Commercial Distribution

  • 04961333229826 ()


  • Electroglottograph
Video Phonetics Program & Database
PENTAX OF AMERICA, INC.
5150
Not in Commercial Distribution

  • 04961333229819 ()


  • Electroglottograph
Motor Speech Products, Software
PENTAX OF AMERICA, INC.
5141
In Commercial Distribution

  • 04961333229802 ()


  • Electroglottograph
Real-Time EGG Analysis Software
PENTAX OF AMERICA, INC.
5138
In Commercial Distribution

  • 04961333229796 ()


  • Electroglottograph
Real-Time Spectrogram Software
PENTAX OF AMERICA, INC.
5129
In Commercial Distribution

  • 04961333229789 ()


  • Electroglottograph
Sona-Match, Software
PENTAX OF AMERICA, INC.
5127
In Commercial Distribution

  • 04961333229772 ()


  • Electroglottograph
Real-Time Pitch Software
PENTAX OF AMERICA, INC.
5121
In Commercial Distribution

  • 04961333229765 ()


  • Electroglottograph
Analysis of Dysphonia in Speech and Voice (ADSV™)
PENTAX OF AMERICA, INC.
5109
In Commercial Distribution

  • 04961333229758 ()


  • Electroglottograph
Multi-Dimensional Voice Program (MDVP) Software
PENTAX OF AMERICA, INC.
5105
In Commercial Distribution

  • 04961333229741 ()


  • Electroglottograph
Analysis-Synthesis Laboratory (ASL) Software
PENTAX OF AMERICA, INC.
5104
Not in Commercial Distribution

  • 04961333229734 ()


  • Electroglottograph
Computerized Speech Lab
PENTAX OF AMERICA, INC.
4500
In Commercial Distribution

  • 04961333229727 ()


  • Electroglottograph
Disordered Voice Database & Program
PENTAX OF AMERICA, INC.
4337
Not in Commercial Distribution

  • 04961333229703 ()


  • Electroglottograph
Palatometer Database Program, Software
PENTAX OF AMERICA, INC.
4333
Not in Commercial Distribution

  • 04961333229697 ()


  • Electroglottograph
Phonetic Database Program, Software
PENTAX OF AMERICA, INC.
4332
Not in Commercial Distribution

  • 04961333229680 ()


  • Electroglottograph
Voice Range Profile S/W Program (VRP)
PENTAX OF AMERICA, INC.
4326
In Commercial Distribution

  • 04961333229673 ()


  • Electroglottograph
Multi-Speech Microphone Preamp
PENTAX OF AMERICA, INC.
3708
In Commercial Distribution

  • 04961333229659 ()


  • Microphone amplifier
Multi-Speech Software
PENTAX OF AMERICA, INC.
3700
In Commercial Distribution

  • 04961333229642 ()


  • Electroglottograph
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