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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This product is intended to be used in combination with FUJIFILM gastrointestinal endoscopes and a FUJIFILM endoscopic CO2 regulator to deliver CO2 gas and water.
FUJIFILM CORPORATION
WT-604G
In Commercial Distribution

  • 04547410366051 ()


  • Surgical irrigation pump
This product is intended for use in combination with FUJIFILM 700 system scopes to deliver air and water through the endoscope under the management of a physician in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
WT-603
In Commercial Distribution

  • 04547410366044 ()


  • Surgical irrigation pump
This product is inteded to be used in combination with FUJIFILM gastrointinal endoscopes and a FUJIFILM endosopic CO2 regulator to deliver CO2 gas and water.
FUJIFILM CORPORATION
AW-604G
In Commercial Distribution

  • 04547410366037 ()


  • Endoscope air/water valve, reusable
The Fujifilm Duodenoscope Model ED-580XT is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FUJIFILM CORPORATION
ED-580XT
In Commercial Distribution

  • 04547410359282 ()
  • 14547410359289 ()


  • Flexible video duodenoscope, reusable
The device is intended for the observation, diagnosis, and endoscopic treatment of trachea and bronchial tree
FUJIFILM CORPORATION
EB-530P
In Commercial Distribution

  • 14547410343202 ()
  • 04547410343205 ()


  • Flexible video bronchoscope, reusable
This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract, airways and tracheobronchial tree under the management of physicians at medical facilities.
FUJIFILM CORPORATION
PB2020-M
In Commercial Distribution

  • 04547410343052 ()


  • Surgical ultrasound imaging transducer
This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
FUJIFILM CORPORATION
EC-530LS V2
In Commercial Distribution

  • 04547410341294 ()


  • Flexible video colonoscope, reusable
This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
FUJIFILM CORPORATION
EC-530HL V2
In Commercial Distribution

  • 04547410341287 ()


  • Flexible video colonoscope, reusable
This device is intended to be installed into the suction valve on the control portion of our ultrasonic endoscope in order to switch suck operation and balloon suck operation selectively. Do not use this product for any other purpose.
FUJIFILM CORPORATION
SB-601
In Commercial Distribution

  • 04547410339437 ()
  • 24547410339431 ()


  • Endoscope suction valve, reusable
This product is a medical device that is attached to a FUJIFILM ultrasonic endoscope in order to jet air or water as well as to feed water into the balloon. Do not use this product for any other purpose.
FUJIFILM CORPORATION
AW-601
In Commercial Distribution

  • 04547410339420 ()
  • 24547410339424 ()


  • Endoscope air/water valve, reusable
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