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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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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-30CR
In Commercial Distribution

  • 14547410331674 ()
  • 04547410331677 ()


  • Endoscope tissue removal cap, single-use
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-29CR
In Commercial Distribution

  • 14547410331667 ()
  • 04547410331660 ()


  • Endoscope tissue removal cap, single-use
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
The Fujifilm Double Balloon Endoscopes are intended for the visualization of the upper and lower digestive tracts. Specifically, for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, large intestine, and rectum.
FUJIFILM CORPORATION
EN-530T
In Commercial Distribution

  • 04547410331646 ()
  • 14547410331643 ()


  • Flexible video enteroscope
This device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FUJIFILM CORPORATION
EG-530CT
In Commercial Distribution

  • 04547410331639 ()
  • 14547410331636 ()


  • Flexible video gastroduodenoscope
This product is intended to confirm airtight of the endoscope.
FUJIFILM CORPORATION
LT-7F
In Commercial Distribution

  • 04547410331615 ()


  • Invasive medical device leak tester, mechanical
This product is intended to supply CO2 gas and feed water to clean lenses in the gastrointestinal tract when used as an accessory with Fujifilm’s endoscopy system.
FUJIFILM CORPORATION
CT-11G
In Commercial Distribution

  • 04547410331608 ()
  • 14547410331605 ()


  • Medical air low pressure hose
This product is intended to supply CO2 gas and feed water to clean lenses in the gastrointestinal tract when used as an accessory with Fujifilm’s endoscopy system.
FUJIFILM CORPORATION
GW-100
In Commercial Distribution

  • 04547410331592 ()


  • Gastrointestinal endoscopic insufflator
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
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-12140
In Commercial Distribution

  • 04547410331493 ()
  • 24547410331497 ()


  • Endoscopic overtube, single-use
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