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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 FUJIFILM ultrasonic processor SP-900 is intended to be used in combination with FUJIFILM Ultrasonic Probe, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree for observation, recording and to aid in diagnosis during endoscopic evaluation. Modes of Operation: B-mode
FUJIFILM CORPORATION
SP-900
In Commercial Distribution

  • 04547410342741 ()


  • General-purpose ultrasound imaging system
This product is intended to clean the distal end and the forceps elevator mechanism of a FUJIFILM endoscope in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
WB1318DE
In Commercial Distribution

  • 14547410341352 ()
  • 04547410341355 ()


  • Surgical instrument/endoscope cleaning utensil, single-use
This product is intended to clean the instrument/suction channel and accessories of a FUJIFILM endoscope in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
WB7025DC
In Commercial Distribution

  • 14547410341345 ()
  • 04547410341348 ()


  • Surgical instrument/endoscope cleaning utensil, single-use
This product is intended to clean the suction valve cylinder, air/water valve cylinder, and instrument channel inlet of a FUJIFILM endoscope, as well as the water pump side connector of the J tube in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
WB11003DV
In Commercial Distribution

  • 14547410341338 ()
  • 04547410341331 ()


  • Surgical instrument/endoscope cleaning utensil, single-use
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
The DR-XD 1000 (FDR AQRO) is a digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. The DR-XD 1000 is not intended for mammography applications.
FUJIFILM CORPORATION
DR-XD 1000
In Commercial Distribution

  • 04547410339161 ()


  • Mobile basic diagnostic x-ray system, digital
This device provides illumination to an endoscope and supplies air and water to body cavities via the endoscope, and is intended to provide images captured by the endoscope for endoscopic procedure.
FUJIFILM CORPORATION
BL-7000
In Commercial Distribution

  • 04547410337730 ()


  • Endoscopic light source unit, line-powered
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