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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 DR-ID 1280MP supplies the power to the flat panel sensor connected by a medical professional and establishes intercommunication between the flat panel sensor and the image processing unit connected beforehand. Also, it transfers images acquired by the flat panel sensor to the image processing unit.
FUJIFILM CORPORATION
DR-ID 1280 MP E
In Commercial Distribution

  • 04547410530636 ()


  • Diagnostic x-ray digital imaging conversion system
The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the digital radiographic images for diagnosis to other devices. The Flat Panel Sensor (DR-ID 128xSE) is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1285 SE E
In Commercial Distribution

  • 04547410530629 ()


  • Diagnostic x-ray digital imaging conversion system
The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the digital radiographic images for diagnosis to other devices. The Flat Panel Sensor (DR-ID 128xSE) is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1284 SE E
In Commercial Distribution

  • 04547410530612 ()


  • Diagnostic x-ray digital imaging conversion system
The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the digital radiographic images for diagnosis to other devices. The Flat Panel Sensor (DR-ID 128xSE) is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1283 SE E
In Commercial Distribution

  • 04547410530605 ()


  • Diagnostic x-ray digital imaging conversion system
The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the digital radiographic images for diagnosis to other devices. The Flat Panel Sensor (DR-ID 128xSE) is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1282 SE E
In Commercial Distribution

  • 04547410530599 ()


  • Diagnostic x-ray digital imaging conversion system
The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the digital radiographic images for diagnosis to other devices. The Flat Panel Sensor (DR-ID 128xSE) is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1281 SE E
In Commercial Distribution

  • 04547410530582 ()


  • Diagnostic x-ray digital imaging conversion system
FUJIFILM Endoscope Model EG-840T, EG-840TP is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FUJIFILM CORPORATION
EG-840TP
In Commercial Distribution

  • 14547410528265 ()
  • 04547410528268 ()


  • Flexible video gastroduodenoscope
This product is intended to be used in combination with the compatible endoscopes, camera head, light source and light guide to adjust the color balance of endoscopic images at medical facilities under the management of physicians. Do not use this product for any other purposes.
FUJIFILM CORPORATION
CB-01B
In Commercial Distribution

  • 04547410524284 ()


  • Endoscope calibration cover, reusable
This interface cable is intended to be used for connecting the light source BL-7000X to the image processing unit EX-0. Do not use this product for any other purposes
FUJIFILM CORPORATION
CC7-402
In Commercial Distribution

  • 04547410522143 ()


  • Electrical-only medical device connection cable, reusable
This product is intended to check whether the FUJIFILM Leak Tester LT-100 can properly test the airtightness of a FUJIFILM endoscope. Do not use this product for any other purposes.
FUJIFILM CORPORATION
CT-2LT
In Commercial Distribution

  • 14547410520917 ()
  • 04547410520910 ()


  • Endoscope leak tester tubing
This product is intended to be used in combination with the FUJIFILM Leak Tester LT-100 to perform leak testing for a FUJIFILM endoscope. Do not use this product for any other purposes.
FUJIFILM CORPORATION
CT-1LT
In Commercial Distribution

  • 04547410520903 ()
  • 14547410520900 ()


  • Endoscope leak tester tubing
Endoscope Model EB-710XT is a bronchoscope intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus at medical facilities under the management of physicians. Never use this product for any other purposes.
FUJIFILM CORPORATION
EB-710XT
In Commercial Distribution

  • 14547410520542 ()
  • 04547410520545 ()


  • Flexible video bronchoscope, reusable
This hood is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
FUJIFILM CORPORATION
DH-096ST
In Commercial Distribution

  • 04547410519945 ()
  • 14547410519942 ()


  • Endoscope tissue removal cap, single-use
FUJIFILM Endoscope Model EG-840T, EG-840TP is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FUJIFILM CORPORATION
EG-840T
In Commercial Distribution

  • 04547410517330 ()
  • 14547410517337 ()


  • Flexible video gastroduodenoscope
This hood is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
FUJIFILM CORPORATION
DH-126STL
In Commercial Distribution

  • 04547410516791 ()
  • 14547410516798 ()


  • Endoscope tissue removal cap, single-use
This hood is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
FUJIFILM CORPORATION
DH-116STL
In Commercial Distribution

  • 04547410516753 ()
  • 14547410516750 ()


  • Endoscope tissue removal cap, single-use
This hood is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
FUJIFILM CORPORATION
DH-106STL
In Commercial Distribution

  • 04547410516715 ()
  • 14547410516712 ()


  • Endoscope tissue removal cap, single-use
This interface cable is intended to be used for connecting the light source BL-7000X to the processor VP-7000X and for connecting the light source BL-7000X to the processor VP-7000 and the image processing unit EX-0 simultaneously. Do not use this product for any other purposes
FUJIFILM CORPORATION
CC7-502
In Commercial Distribution

  • 04547410516258 ()


  • Electrical-only medical device connection cable, reusable
This product is intended to be used in combination with the compatible endoscopes, camera head, light source and light guide to adjust the color balance of endoscopic images at medical facilities under the management of physicians. Do not use this product for any other purposes.
FUJIFILM CORPORATION
CB-01P
In Commercial Distribution

  • 04547410515893 ()
  • 14547410515890 ()


  • Endoscope calibration cover, single-use
This product is intended to be used as an accessory with the FUJIFILM Double Balloon Endoscope cleared for use with an Over-tube. The Over-tube is used to assist with the movement of the scope inside the upper or lower digestive tract. This product is not intended for use for any neonates, infants or children.
FUJIFILM CORPORATION
TS-1214C
In Commercial Distribution

  • 14547410514053 ()
  • 04547410514056 ()


  • Endoscopic overtube, single-use
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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