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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FUJIFILM Endoscope Model EG-580UR is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of submucosal and peripheral organs of the esophagus, stomach, and duodenum.
FUJIFILM CORPORATION
EG-580UR
In Commercial Distribution

  • 14547410349075 ()
  • 04547410349078 ()


  • Flexible ultrasound gastroduodenoscope
FUJIFILM Endoscope Model EG-580UT is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of submucosal and peripheral organs of the esophagus, stomach, and duodenum.
FUJIFILM CORPORATION
EG-580UT
In Commercial Distribution

  • 14547410349068 ()
  • 04547410349061 ()


  • Flexible ultrasound gastroduodenoscope
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 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
The device is intended for the observation, diagnosis, and endoscopic treatment of trachea and bronchial tree
FUJIFILM CORPORATION
EB-530S
In Commercial Distribution

  • 04547410333312 ()
  • 14547410333319 ()


  • Flexible video bronchoscope, 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-530DL
In Commercial Distribution

  • 04547410333305 ()
  • 14547410333302 ()


  • 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 sigmoid colon.
FUJIFILM CORPORATION
ES-530WE
In Commercial Distribution

  • 04547410333299 ()
  • 14547410333296 ()


  • Flexible video sigmoidoscope, reusable
This product is used to keep a patient's mouth open while using an endoscope under the management of a physician in medical facilities. Do not use this product for any other purposes.
FUJIFILM CORPORATION
MPC-ST
In Commercial Distribution

  • 84547410333264 ()
  • 04547410333268 ()


  • Endoscopic bite block, basic, reusable
This product is used to keep a patient's mouth open while using an endoscope under the management of a physician in medical facilities. Do not use this product for any other purposes.
FUJIFILM CORPORATION
MPC-P
In Commercial Distribution

  • 84547410333257 ()
  • 04547410333251 ()


  • Endoscopic bite block, basic, reusable
This product is a balloon pump apparatus intended to inflate or deflate a balloon to assist with endoscope and over tube insertion. This product is not intended for use for any neonates, infants or children.
FUJIFILM CORPORATION
TY-06D
In Commercial Distribution

  • 04547410332100 ()


  • Medical air low pressure hose
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