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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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FUJIFILM - 04547410449723

FUJIFILM Video Laparoscope EL-R740M30 is intended to be used with a video processor, light source, monitor, hand instruments, electrosurgical unit and other ancillary equipment for minimally invasive observation, diagnosis and treatment in general abdominal, gynecologic and thoracic areas.
FUJIFILM CORPORATION
EL-R740M30
In Commercial Distribution

  • 14547410449720 ()
  • 04547410449723 ()


  • Rigid video laparoscope

FUJIFILM - 04547410446142

This product is intended to be used in combination with the FUJIFILM ultrasonic endoscope to enclose the ultrasonic transmission medium in medical facilities under the management of physicians. Do not use this product for any other purpose. This product is not intended for use on children and infants.
FUJIFILM CORPORATION
BS-102
In Commercial Distribution

  • 14547410446149 ()
  • 04547410446142 ()
  • 84547410446148 ()


  • Ultrasound endoscope balloon, synthetic polymer

FUJIFILM - 04547410445886

This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree under the management of physicians at medical facilities. Modes of Operation: B-mode Never use this product for any other purposes
FUJIFILM CORPORATION
PB2020-M2
In Commercial Distribution

  • 04547410445886 ()


  • Surgical ultrasound imaging transducer

FUJIFILM - 04547410438956

This device is intended to be used with a video processor, light sourse, monitor, hand instruments, electorosurgical unit and other ancillary equipment for minimally invasive observation, diagnosis and treatment in general abdominal, gynecologic and thoracic areas.
FUJIFILM CORPORATION
EL-R740M
In Commercial Distribution

  • 04547410438956 ()
  • 14547410438953 ()


  • Rigid video laparoscope

FUJIFILM - 04547410438673

This product is exclusively used for manual cleaning and manual disinfection of a FUJIFILM endoscope in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CA-617
In Commercial Distribution

  • 04547410438673 ()
  • 24547410438677 ()


  • Luminal device flushing tubing set, reusable

FUJIFILM - 04547410438604

This product is inteded to supply air, water or detergent slution to the air/water channel during manual cleaning of a FUJIFILM endoscope in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CA-614
In Commercial Distribution

  • 24547410438608 ()
  • 04547410438604 ()


  • Luminal device flushing tubing set, reusable

FUJIFILM - 04547410436501

FUJIFILM Endoscope Model EI-740D/S is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. This device is also 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
EI-740D/S
In Commercial Distribution

  • 04547410436501 ()
  • 14547410436508 ()


  • Flexible video upper/lower gastrointestinal endoscope

FUJIFILM - 04547410432589

This product is intended to attach a balloon to a FUJIFILM endoscope in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
BA-03
In Commercial Distribution

  • 24547410432583 ()
  • 04547410432589 ()


  • Endoscope balloon positioner, reusable

FUJIFILM - 04547410426380

This product is attached to the instrument channel inlet of a FUJIFILM endoscope at medical facilities under the management of physicians. It is intended to insert an endotherapy device, to prevent leak or backflow of air and/or fluids and to enable the suction function of an endoscope. Do not use this product for any other purpose.
FUJIFILM CORPORATION
FV-002
In Commercial Distribution

  • 24547410426384 ()
  • 04547410426380 ()
  • 84547410426386 ()


  • Endoscope working-channel valve, single-use

FUJIFILM - 04547410425178

This product is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. Never use this product for any other purposes.
FUJIFILM CORPORATION
EC-760S-A/L
In Commercial Distribution

  • 14547410425175 ()
  • 04547410425178 ()


  • Flexible video colonoscope, reusable
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