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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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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
The Fujifilm ultrasonic processors SU-1 is intended to be used in combination with Fujifilm ultrasonic endoscope, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the trachea, bronchial tree and surrounding organs, or submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation.
FUJIFILM CORPORATION
SU-1 FV667A
In Commercial Distribution

  • 04547410332377 ()


  • General-purpose ultrasound imaging system
The Fujifilm ultrasonic processors SU-1 PLATINUM is intended to be used in combination with Fujifilm ultrasonic endoscope, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the trachea, bronchial tree and surrounding organs, or submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation.
FUJIFILM CORPORATION
SU-1 PLATINUM FV666A
In Commercial Distribution

  • 04547410332360 ()


  • General-purpose ultrasound imaging system
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
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-04D
In Commercial Distribution

  • 04547410332094 ()


  • Medical air low pressure hose
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
PB-30
In Commercial Distribution

  • 04547410332063 ()


  • Catheter/overtube balloon inflator, reusable
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