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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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Self Adherent Bandage Coban
BIOSEAL
4015/30
In Commercial Distribution

  • 10630094040155 ()
  • 00630094040158 ()


  • Pressure bandage, non-latex, single-use
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
Balloon For EG-3270UK OE-A56
HOYA CORPORATION
OE-A56
In Commercial Distribution

  • 84961333253926 ()
  • 04961333253920 ()


  • Ultrasound endoscope balloon, synthetic polymer
PENTAX Balloon OE-A52
HOYA CORPORATION
OE-A52
In Commercial Distribution

  • 84961333253919 ()
  • 04961333253913 ()


  • Ultrasound endoscope balloon, synthetic polymer
Balloon OE-A51
HOYA CORPORATION
OE-A51
In Commercial Distribution

  • 84961333253902 ()
  • 04961333253906 ()


  • Ultrasound endoscope balloon, synthetic polymer
PENTAX Medical Gas/Water Feeding Valve OE-B14
HOYA CORPORATION
OE-B14
In Commercial Distribution

  • 04961333252121 ()


  • Endoscope air/water valve, reusable
PENTAX Gas/Water Feeding Valve OF-B194
HOYA CORPORATION
OF-B194
In Commercial Distribution

  • 04961333251070 ()


  • Endoscope air/water valve, reusable
STANDALONE IMAGE CAPTURE PC
PENTAX OF AMERICA, INC.
KBM68407
In Commercial Distribution

  • 04961333245291 ()


  • Radiology information system
PROFILE SINGLE USE ENDOSCOPE CLEANING BR
PENTAX OF AMERICA, INC.
CS-C11A
In Commercial Distribution

  • 04961333242856 ()


  • Surgical instrument/endoscope cleaning utensil, single-use
PROFILE SINGLE USE ENDOSCOPE CLEANING BR
PENTAX OF AMERICA, INC.
CS-4010A
In Commercial Distribution

  • 04961333242818 ()


  • Surgical instrument/endoscope cleaning utensil, single-use
MEDICAP USB 300
PENTAX OF AMERICA, INC.
9139HD
In Commercial Distribution

  • 04961333242184 ()


  • Digital storage media
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