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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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This product is a leak tester for the purpose of pressurizing the inside of the endoscope and confirming that there is no airtight leakage of the endoscope in medical facilities. Do not use for any other purpose.
FUJIFILM CORPORATION
LT-100
In Commercial Distribution

  • 04547410512236 ()


  • Invasive medical device leak tester, electrical
This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract and surrounding organs under the management of physicians at medical facilities. This product is intended for adults. Modes of Operation: B-mode Never use this product for any other purposes.
FUJIFILM CORPORATION
P2620S-L
In Commercial Distribution

  • 04547410509991 ()


  • Surgical ultrasound imaging transducer
This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract and surrounding organs under the management of physicians at medical facilities. This product is intended for adults. Modes of Operation: B-mode Never use this product for any other purposes.
FUJIFILM CORPORATION
P2612S-L
In Commercial Distribution

  • 04547410509984 ()


  • Surgical ultrasound imaging transducer
FUJIFILM Endoscope Model EG-840N 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 product can be inserted orally or nasally. Never use this product for any other purposes.
FUJIFILM CORPORATION
EG-840N
In Commercial Distribution

  • 14547410500643 ()
  • 04547410500646 ()


  • Flexible video gastroduodenoscope
"This device is intended for the visualization of the upper and lower digestive tracts, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, large intestine and rectum. Never use this product for any other purposes. "
FUJIFILM CORPORATION
EN-840T
In Commercial Distribution

  • 14547410491712 ()
  • 04547410491715 ()


  • Flexible video enteroscope
This product is intended to be used in combination with an endoscope to assist endoscopic insertion into the body. Never use this product for any other purpose. This product is intended for use in medical facilities by medical professionals who are properly trained in using it as well as in endoscopic procedures and endoscopic treatments.
FUJIFILM CORPORATION
TR-1504A
In Commercial Distribution

  • 14547410484745 ()
  • 04547410484748 ()


  • Endoscopic overtube, single-use
This product is intended to be used in combination with an endoscope to assist endoscopic insertion into the body. Never use this product for any other purpose. This product is intended for use in medical facilities by medical professionals who are properly trained in using it as well as in endoscopic procedures and endoscopic treatments.
FUJIFILM CORPORATION
TR-1507A
In Commercial Distribution

  • 14547410484714 ()
  • 04547410484717 ()


  • Endoscopic overtube, single-use
This product is intended to be used in combination with an endoscope to assist endoscopic insertion into the body. Never use this product for any other purpose. This product is intended for use in medical facilities by medical professionals who are properly trained in using it as well as in endoscopic procedures and endoscopic treatments.
FUJIFILM CORPORATION
TR-1208A
In Commercial Distribution

  • 14547410484684 ()
  • 04547410484687 ()


  • Endoscopic overtube, single-use
Protective cover is placed on a flat panel sensor (DR-ID 1836SE) during recumbent exposure and is covered to reinforce the strength.
FUJIFILM CORPORATION
DR1836 SE PROTECTIVE COVER E
In Commercial Distribution

  • 04547410483437 ()

  • 470x860x25mm


  • Stationary basic diagnostic x-ray system, digital
The DR-ID 1836SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1836 SE E
In Commercial Distribution

  • 04547410483420 ()

  • 460x850x15mm


  • Stationary basic diagnostic x-ray system, digital
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