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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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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
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
WATERJET CONN, DISP, SINGLE, 10/PKG
PENTAX OF AMERICA, INC.
100242P
Not in Commercial Distribution

  • 04961333241774 ()
  • 14961333241771 ()


  • Endoscope air/water valve, single-use
PENTAX DISPOCAP AIR, 10/PKG
PENTAX OF AMERICA, INC.
100160P
Not in Commercial Distribution

  • 04961333241767 ()
  • 14961333241764 ()


  • Endoscopic insufflation tubing set, single-use
PENTAX DISPOCAP CO2, 10/PKG
PENTAX OF AMERICA, INC.
100150CO2P
Not in Commercial Distribution

  • 04961333241750 ()
  • 14961333241757 ()


  • Endoscopic insufflation tubing set, single-use
CHANNEL ADAPTER SINGLE USE PKG 10
PENTAX OF AMERICA, INC.
100136P
In Commercial Distribution

  • 04961333241743 ()
  • 14961333241740 ()


  • Surgical fluid/gas irrigator
BIOPSY TUBING,SINGLE USE PKG 10
PENTAX OF AMERICA, INC.
100135P
In Commercial Distribution

  • 04961333241736 ()
  • 14961333241733 ()


  • Surgical fluid/gas irrigator
IRRIG TUBING, EGA-500P, 10/PKG
PENTAX OF AMERICA, INC.
100130P
Not in Commercial Distribution

  • 04961333241729 ()
  • 14961333241726 ()


  • Surgical fluid/gas irrigator
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