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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CART, STROBE HUI
PENTAX OF AMERICA, INC.
9272
In Commercial Distribution

  • 04961333231126 ()


  • Endoscope transport trolley
OTOSCOPE 3MM, 69MM LONG
PENTAX OF AMERICA, INC.
8868
In Commercial Distribution

  • 04961333231119 ()

  • Length: 69 Millimeter
  • Outer Diameter: 3.0 Millimeter


  • Rigid optical nasopharyngoscope
COMPUTER, SIGNALS LAB
PENTAX OF AMERICA, INC.
7207
Not in Commercial Distribution

  • 04961333231102 ()


  • Manometric gastrointestinal motility analysis system
SYNC MODULE FOR FULL SYSTEM
PENTAX OF AMERICA, INC.
7127
Not in Commercial Distribution

  • 04961333231089 ()


  • Manometric gastrointestinal motility analysis system
TONGUE HARDWARE W/25 ARRAYS
PENTAX OF AMERICA, INC.
7124
In Commercial Distribution

  • 04961333231072 ()


  • Manometric gastrointestinal motility analysis system
30 ADULT LARGE DISPOSABLE MASK
PENTAX OF AMERICA, INC.
6645
In Commercial Distribution

  • 04961333231065 ()
  • 14961333231062 ()


  • Electroglottograph
30 ADULT MED. DISPOSABLE MASKS
PENTAX OF AMERICA, INC.
6635
In Commercial Distribution

  • 04961333231058 ()
  • 14961333231055 ()


  • Electroglottograph
30 ADULT SMALL DISPOSABLE MASK
PENTAX OF AMERICA, INC.
6625
In Commercial Distribution

  • 04961333231041 ()
  • 14961333231048 ()


  • Electroglottograph
30 PEDIATRIC DISPOSABLE MASKS
PENTAX OF AMERICA, INC.
6615
In Commercial Distribution

  • 04961333231034 ()
  • 14961333231031 ()


  • Electroglottograph
HEADSET CUSHIONS
PENTAX OF AMERICA, INC.
6455
In Commercial Distribution

  • 04961333231027 ()
  • 14961333231024 ()


  • Electroglottograph
HAND-HELD SEPARATOR KIT
PENTAX OF AMERICA, INC.
6453
In Commercial Distribution

  • 04961333231010 ()


  • Electroglottograph
ACCELERAMETER ASSEMBLY
PENTAX OF AMERICA, INC.
3203
Not in Commercial Distribution

  • 04961333231003 ()


  • Electroglottograph
Phonatory Aerodynamic System for CSL, Model 4500 Users
PENTAX OF AMERICA, INC.
6600-1
In Commercial Distribution

  • 04961333230624 ()


  • Electroglottograph
Endoscope Adaptor
PENTAX OF AMERICA, INC.
9122D
In Commercial Distribution

  • 04961333230594 ()


  • Rigid optical nasopharyngoscope
Light Cable Kit w/ Connector Model 8871
PENTAX OF AMERICA, INC.
8870KIT
In Commercial Distribution

  • 04961333230587 ()


  • Rigid optical nasopharyngoscope
Sinuscope 4.0mm, 70 Wide Angle
PENTAX OF AMERICA, INC.
8856-WA
In Commercial Distribution

  • 04961333230570 ()

  • Angle: 70 degree
  • Outer Diameter: 4.0 Millimeter


  • Rigid optical nasopharyngoscope
Sinuscope 4.0mm, 45 Wide Angle
PENTAX OF AMERICA, INC.
8855-WA
In Commercial Distribution

  • 04961333230563 ()

  • Angle: 45 degree
  • Outer Diameter: 4.0 Millimeter


  • Rigid optical nasopharyngoscope
Sinuscope 4.0mm, 30 Wide Angle
PENTAX OF AMERICA, INC.
8854-WA
In Commercial Distribution

  • 04961333230556 ()

  • Angle: 30 degree
  • Outer Diameter: 4.0 Millimeter


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

  • 04961333230549 ()

  • Angle: 0 degree
  • Outer Diameter: 4.0 Millimeter


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

  • 04961333230532 ()

  • Angle: 70 degree
  • Outer Diameter: 2.7 Millimeter


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

  • 04961333230525 ()

  • Angle: 30 degree
  • Outer Diameter: 2.7 Millimeter


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

  • 04961333230518 ()

  • Angle: 0 degree
  • Outer Diameter: 2.7 Millimeter


  • Rigid optical nasopharyngoscope
Flowhead Tubes, Set of 8
PENTAX OF AMERICA, INC.
7189-4200
In Commercial Distribution

  • 04961333230501 ()
  • 14961333230508 ()


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

  • 04961333230495 ()
  • 34961333230496 ()


  • Manometric gastrointestinal motility analysis system
EGG Electrodes, Adult
PENTAX OF AMERICA, INC.
7183-3200
In Commercial Distribution

  • 04961333230488 ()


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

  • 04961333230464 ()
  • 34961333230465 ()


  • Manometric gastrointestinal motility analysis system
Tongue Arrays
PENTAX OF AMERICA, INC.
7179-0035
In Commercial Distribution

  • 04961333230457 ()
  • 34961333230458 ()


  • Manometric gastrointestinal motility analysis system
Nasal Cannulas
PENTAX OF AMERICA, INC.
7179-0030
In Commercial Distribution

  • 04961333230440 ()
  • 14961333230446 ()


  • Manometric gastrointestinal motility analysis system
Electrodes
PENTAX OF AMERICA, INC.
7179-0025
In Commercial Distribution

  • 04961333230433 ()
  • 14961333230439 ()


  • Manometric gastrointestinal motility analysis system
Electrodes
PENTAX OF AMERICA, INC.
7179-0020
In Commercial Distribution

  • 04961333230426 ()
  • 14961333230422 ()


  • Manometric gastrointestinal motility analysis system
EGG Electrode Straps (3 Sizes)
PENTAX OF AMERICA, INC.
7175-6100
In Commercial Distribution

  • 04961333230419 ()


  • Electroglottograph
Headset Cushions/Seal for Nasometer
PENTAX OF AMERICA, INC.
7163-7200
In Commercial Distribution

  • 04961333230402 ()
  • 14961333230409 ()


  • Electroglottograph
Upgrade - Software Only
PENTAX OF AMERICA, INC.
5298 VU
Not in Commercial Distribution

  • 04961333230389 ()


  • Electroglottograph
Upgrade for CSL 4150
PENTAX OF AMERICA, INC.
4150 VU
Not in Commercial Distribution

  • 04961333230372 ()


  • Electroglottograph
Upgrade for Visi-Pitch IV, 3950
PENTAX OF AMERICA, INC.
3950 VU
Not in Commercial Distribution

  • 04961333230365 ()


  • Electroglottograph
Vocal Parts and Vocal Pathology I & II Software
PENTAX OF AMERICA, INC.
9225
In Commercial Distribution

  • 04961333230358 ()


  • Electroglottograph
Video Viewer for KayPENTAX Digital Video
PENTAX OF AMERICA, INC.
9221
In Commercial Distribution

  • 04961333230341 ()


  • Video cassette recorder
Isolation Transformer
PENTAX OF AMERICA, INC.
9175
In Commercial Distribution

  • 04961333230334 ()


  • Constant-voltage transformer
Connector to Light Source
PENTAX OF AMERICA, INC.
8879
In Commercial Distribution

  • 04961333230327 ()


  • Rigid optical nasopharyngoscope
Connector to Light Source
PENTAX OF AMERICA, INC.
8878
Not in Commercial Distribution

  • 04961333230310 ()


  • Rigid optical nasopharyngoscope
Connector to Light Source
PENTAX OF AMERICA, INC.
8877
In Commercial Distribution

  • 04961333230303 ()


  • Rigid optical nasopharyngoscope
Connector to Light Source
PENTAX OF AMERICA, INC.
8876
In Commercial Distribution

  • 04961333230297 ()


  • Rigid optical nasopharyngoscope
Connector to Light Source
PENTAX OF AMERICA, INC.
8875
In Commercial Distribution

  • 04961333230280 ()


  • Rigid optical nasopharyngoscope
Connector to Light Source
PENTAX OF AMERICA, INC.
8874
In Commercial Distribution

  • 04961333230273 ()


  • Rigid optical nasopharyngoscope
Connector to scope
PENTAX OF AMERICA, INC.
8873
Not in Commercial Distribution

  • 04961333230266 ()


  • Rigid optical nasopharyngoscope
Connector to scope
PENTAX OF AMERICA, INC.
8872
In Commercial Distribution

  • 04961333230259 ()


  • Rigid optical nasopharyngoscope
Connector to scope
PENTAX OF AMERICA, INC.
8871
In Commercial Distribution

  • 04961333230242 ()


  • Rigid optical nasopharyngoscope
Adaptable Tube
PENTAX OF AMERICA, INC.
8860
In Commercial Distribution

  • 04961333230228 ()


  • Rigid optical nasopharyngoscope
Sinuscope 4.0mm, 70
PENTAX OF AMERICA, INC.
8856
In Commercial Distribution

  • 04961333230211 ()

  • Angle: 70 degree
  • Outer Diameter: 4.0 Millimeter


  • Rigid optical nasopharyngoscope
Sinuscope 4.0mm, 45
PENTAX OF AMERICA, INC.
8855
In Commercial Distribution

  • 04961333230204 ()

  • Angle: 45 degree
  • Outer Diameter: 4.0 Millimeter


  • Rigid optical nasopharyngoscope
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