Home GUDID 00840253111043 Fuse®
Primary DI 00840253111043
Brand Fuse®
Company ENDOCHOICE, INC.
Model FDEMO-H7642
Device description Gastroscope
Published 2016-09-08
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Product Codes# Code, Name table Code Name FDS Gastroscope And Accessories, Flexible/Rigid
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840253111043 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00840253111043 00840253111043 840253111043 0840253111043
GMDN Terms# Term, Definition table Term Definition Flexible video gastroscope An endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus and the stomach. It is inserted into the body through the mouth during gastroscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end and of the endoscope and the images showing on a monitor. This device is commonly used in the evaluation or treatment of unusual abdominal pain, bleeding, cancer, chronic heartburn, polyps, gastritis, ulcers, or hiatal hernia. Physicians may also use the device to obtain biopsies or perform other procedures. This is a reusable device.
Regulatory Flags# DUNS number 014154279 Device count 1 Serial number true Manufacturing date on label true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08809882470213 ROBOPERA™ SET EndoRobotics Co., Ltd. FDS 2026-10-16 08809882470220 Articulated Basic Gripper G EndoRobotics Co., Ltd. FDS 2026-10-16 08809882470237 Articulated Dual Gripper G EndoRobotics Co., Ltd. FDS 2026-10-16 08809882470381 ROBOPERA™ Unit EndoRobotics Co., Ltd. FDS 2026-10-16 08809882470398 ROBOPERA™ EndoRobotics Co., Ltd. FDS 2026-10-16 08809882470404 Controller A EndoRobotics Co., Ltd. FDS 2026-10-16 08809882470428 Controller B EndoRobotics Co., Ltd. FDS 2026-10-16 08809882470442 ROBOPERA™ Accessories EndoRobotics Co., Ltd. FDS 2026-10-16 08809882470466 R-Power Cable EndoRobotics Co., Ltd. FDS 2026-10-16 08809882470725 ROBOPERA™ Storage Case EndoRobotics Co., Ltd. FDS 2026-10-16 04580826920035 PENTAX Medical PENTAX MEDICAL CORPORATION FDS 2026-08-25 04580826920066 PENTAX Medical PENTAX MEDICAL CORPORATION FDS 2026-08-25 04580826920141 PENTAX Medical PENTAX MEDICAL CORPORATION FDS 2026-08-25 04580826920271 PENTAX Medical PENTAX MEDICAL CORPORATION FDS 2026-08-25 04580826920325 PENTAX Medical PENTAX MEDICAL CORPORATION FDS 2026-08-25 04580826920660 PENTAX Medical PENTAX MEDICAL CORPORATION FDS 2026-08-25 04580826921230 PENTAX Medical PENTAX MEDICAL CORPORATION FDS 2026-08-25 04580826921278 PENTAX Medical PENTAX MEDICAL CORPORATION FDS 2026-08-25 04580826921353 PENTAX Medical PENTAX MEDICAL CORPORATION FDS 2026-08-25 04580826921865 PENTAX Medical PENTAX MEDICAL CORPORATION FDS 2026-08-25 04580826921940 PENTAX Medical PENTAX MEDICAL CORPORATION FDS 2026-08-25 04580826921957 PENTAX Medical PENTAX MEDICAL CORPORATION FDS 2026-08-25 04580826925672 PENTAX Medical PENTAX MEDICAL CORPORATION FDS 2026-08-25 04580826925702 PENTAX Medical PENTAX MEDICAL CORPORATION FDS 2026-08-25 04580826925832 PENTAX Medical PENTAX MEDICAL CORPORATION FDS 2026-08-25 04580826926068 PENTAX Medical PENTAX MEDICAL CORPORATION FDS 2026-08-25 04580826926075 PENTAX Medical PENTAX MEDICAL CORPORATION FDS 2026-08-25 04580826926082 PENTAX Medical PENTAX MEDICAL CORPORATION FDS 2026-08-25 04580826926099 PENTAX Medical PENTAX MEDICAL CORPORATION FDS 2026-08-25 04580826926136 PENTAX Medical PENTAX MEDICAL CORPORATION FDS 2026-08-25