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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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9500FS, Footswitch "Accessory for 9500 "
PENTAX OF AMERICA, INC.
9500FS
In Commercial Distribution

  • 04961333255726 ()


  • Laryngostroboscope
9500MC, Lapel Microphone "Accessory for 9500"
PENTAX OF AMERICA, INC.
9500MC
In Commercial Distribution

  • 04961333255719 ()


  • Laryngostroboscope
9500LX, Laryngeal Microphone "Accessory for 9500"
PENTAX OF AMERICA, INC.
9500LX
In Commercial Distribution

  • 04961333255702 ()


  • Laryngostroboscope
No Description
PENTAX OF AMERICA, INC.
FG-1056
In Commercial Distribution

  • 04961333255320 ()


  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
No Description
PENTAX OF AMERICA, INC.
FG-1055
In Commercial Distribution

  • 04961333255313 ()


  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
LARYNGEAL STROBE 9500
PENTAX OF AMERICA, INC.
9500
In Commercial Distribution

  • 04961333255016 ()


  • Laryngostroboscope
Multi-Speech Microphone, Condensor
PENTAX OF AMERICA, INC.
3706-1
In Commercial Distribution

  • 04961333254309 ()


  • Voice amplification system
Balloon/O-Ring Kit OF-A67
HOYA CORPORATION
OF-A67
In Commercial Distribution

  • 84961333253957 ()
  • 04961333253951 ()


  • Ultrasound endoscope balloon, synthetic polymer
PENTAX Medical Single Use Balloon OE-A61
HOYA CORPORATION
OE-A61
In Commercial Distribution

  • 84961333253940 ()
  • 04961333253944 ()


  • Ultrasound endoscope balloon, synthetic polymer
PENTAX Medical Single Use Balloon OE-A60
HOYA CORPORATION
OE-A60
In Commercial Distribution

  • 84961333253933 ()
  • 04961333253937 ()


  • Ultrasound endoscope balloon, synthetic polymer
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