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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These hoods are intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
FUJIFILM CORPORATION
DH-28GR
In Commercial Distribution

  • 14547410331650 ()
  • 04547410331653 ()


  • Endoscope tissue removal cap, single-use
These sterile Over-tubes are intended to be used as accessories with the FUJINON/ FUJIFILM Double Balloon Endoscopes cleared for use with Over-tubes. The Over-tubes are used to assist with the movement of the scopes inside the upper or lower digestive tract. This product is not intended for use for any neonates, infants or children.
FUJIFILM CORPORATION
TS-13140
In Commercial Distribution

  • 04547410331516 ()
  • 24547410331510 ()


  • Endoscopic overtube, single-use
This product is used in combination with a FUJINON/FUJIFILM Endoscope to assist the insertion of the Endoscope under the management of physicians in medical facilities. Never use this product for any other purposes. This product is not intended for use for any child or baby.
FUJIFILM CORPORATION
TS-13101
In Commercial Distribution

  • 04547410331509 ()
  • 24547410331503 ()


  • Endoscopic overtube, single-use
This product is intended to be used in combination with an endoscope to assist endoscopic insertion into the body. Never use this product for any other purpose. This product is intended for use in medical facilities by medical professionals who are properly trained in using it as well as in endoscopic procedures and endoscopic treatments.
FUJIFILM CORPORATION
TR-1108A
In Commercial Distribution

  • 04547410543858 ()
  • 14547410543855 ()


  • Endoscopic overtube, single-use
This hood is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
FUJIFILM CORPORATION
DH-083ST
In Commercial Distribution

  • 14547410532873 ()
  • 04547410532876 ()


  • Endoscope tissue removal cap, single-use
This hood is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
FUJIFILM CORPORATION
DH-096ST
In Commercial Distribution

  • 04547410519945 ()
  • 14547410519942 ()


  • Endoscope tissue removal cap, single-use
This hood is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
FUJIFILM CORPORATION
DH-126STL
In Commercial Distribution

  • 04547410516791 ()
  • 14547410516798 ()


  • Endoscope tissue removal cap, single-use
This hood is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
FUJIFILM CORPORATION
DH-116STL
In Commercial Distribution

  • 04547410516753 ()
  • 14547410516750 ()


  • Endoscope tissue removal cap, single-use
This hood is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
FUJIFILM CORPORATION
DH-106STL
In Commercial Distribution

  • 04547410516715 ()
  • 14547410516712 ()


  • Endoscope tissue removal cap, single-use
This product is intended to be used in combination with the compatible endoscopes, camera head, light source and light guide to adjust the color balance of endoscopic images at medical facilities under the management of physicians. Do not use this product for any other purposes.
FUJIFILM CORPORATION
CB-01P
In Commercial Distribution

  • 04547410515893 ()
  • 14547410515890 ()


  • Endoscope calibration cover, single-use
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