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 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 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
This product is used in medical facilities and attached to the forceps inlet of endoscope to prevent leak or backflow of air. Do not use this product for any other purpose.
FUJIFILM CORPORATION
FV-003
In Commercial Distribution

  • 14547410480990 ()
  • 04547410480993 ()


  • Endoscope working-channel valve, single-use
This product is a medical device that is attached to a FUJIFILM endoscope in order to control the suctioning of body fluids, etc. through the instrument channel of the endoscopes. Do not use this product for any other purpose.
FUJIFILM CORPORATION
SB-606
In Commercial Distribution

  • 14547410480983 ()
  • 04547410480986 ()


  • Endoscope suction valve, single-use
These products are used in combination with an applicable endoscope to perform the endoscopic treatments for the target site in the gastrointestinal tract, such as ablation, incision, dissection, cauterization, coagulation and avulsion of tissue and arrest of bleeding, and to inject saline or submucosal injection agent for endoscopic surgery into the submucosal layer in the gastrointestinal tract, which is exposed after dissection, under the management of physicians in medical facilities. Never use this product for any other purpose.
FUJIFILM CORPORATION
DK2623JI -B20-
In Commercial Distribution

  • 04547410470543 ()
  • 14547410470540 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
These products are used in combination with an applicable endoscope to perform the endoscopic treatments for the target site in the gastrointestinal tract, such as ablation, incision, dissection, cauterization, coagulation and avulsion of tissue and arrest of bleeding, and to inject saline or submucosal injection agent for endoscopic surgery into the submucosal layer in the gastrointestinal tract, which is exposed after dissection, under the management of physicians in medical facilities. Never use this product for any other purpose.
FUJIFILM CORPORATION
DK2623JI -B15-
In Commercial Distribution

  • 14547410470533 ()
  • 04547410470536 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
These products are used in combination with an applicable endoscope to perform the endoscopic treatments for the target site in the gastrointestinal tract, such as ablation, incision, dissection, cauterization, coagulation and avulsion of tissue and arrest of bleeding, and to inject saline or submucosal injection agent for endoscopic surgery into the submucosal layer in the gastrointestinal tract, which is exposed after dissection, under the management of physicians in medical facilities. Never use this product for any other purpose.
FUJIFILM CORPORATION
DK2623JI -N20-
In Commercial Distribution

  • 14547410470526 ()
  • 04547410470529 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
These products are used in combination with an applicable endoscope to perform the endoscopic treatments for the target site in the gastrointestinal tract, such as ablation, incision, dissection, cauterization, coagulation and avulsion of tissue and arrest of bleeding, and to inject saline or submucosal injection agent for endoscopic surgery into the submucosal layer in the gastrointestinal tract, which is exposed after dissection, under the management of physicians in medical facilities. Never use this product for any other purpose.
FUJIFILM CORPORATION
DK2623JI -N15-
In Commercial Distribution

  • 14547410470519 ()
  • 04547410470512 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
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