Home GUDID 14547410349068 FUJIFILM
Primary DI 14547410349068
Brand FUJIFILM
Company FUJIFILM CORPORATION
Model EG-580UT
Device description FUJIFILM Endoscope Model EG-580UT is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of submucosal and peripheral organs of the esophagus, stomach, and duodenum.
Published 2019-09-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name FDS Gastroscope And Accessories, Flexible/Rigid ITX Transducer, Ultrasonic, Diagnostic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology 2 ITX Transducer, Ultrasonic, Diagnostic Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 14547410349068 Package GS1 1 In Commercial Distribution 04547410349061 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 14547410349068 14547410349068 04547410349061 04547410349061 4547410349061
GMDN Terms# Term, Definition table Term Definition Flexible ultrasound gastroduodenoscope An endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. It is inserted into the body through the mouth during gastroduodenoscopy. Anatomical images are transmitted to the user through a fibreoptic bundle or a video system and the ultrasound probe. The probe may be built-in, or inserted through a dedicated lumen. This device is commonly used to examine structures of the stomach, duodenum, pancreas, and bile duct. This is a reusable device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Handling Environment Humidity 30 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Handling Environment Temperature 10 Degrees Celsius 40 Degrees Celsius Special Storage Condition, Specify 0 0 There must be no condensation. Storage Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Storage Environment Temperature -20 Degrees Celsius 60 Degrees Celsius
Sterilization Methods# Method table Method Ethylene Oxide;High-level Disinfectant
Regulatory Flags# DUNS number 713565195 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 04547410582901 FDR CROSS Slim DR-XD 3000 SLIM MBL E 2026-08-14 04547410524642 FUJIFILM EB-840T 2026-07-30 04547410524680 FUJIFILM EB-840S 2026-07-30 04573596212318 S3ESCLS S3ESCLS 2024-01-25 04573596212325 S3ESEL S3ESEL 2021-07-18 04573596201367 OASIS MR-NVC-120 OASIS RAPID NV Coil MR-NVC-120 2026-05-29 04573596201398 OASIS MR-QFC-120 OASIS QD Flexible Body Coil(L) MR-QFC-120 2026-05-29 04573596201404 OASIS MR-QFC-120XL OASIS QD Flexible Body Coil(XL) MR-QFC-120XL 2026-05-29 04573596201411 OASIS MR-RFC-120 OASIS RAPID Foot Coil MR-RFC-120 2026-05-29 04573596201435 OASIS MR-CTL-120 OASIS CTL Coil MR-CTL-120 2026-05-29 04573596202159 OASIS MR-IBC-120 OASIS RAPID Breast Coil MR-IBC-120 2026-05-29 04547410480269 FUJIFILM VS-1000 2026-05-22 04547410529128 FUJIFILM EG-S100XT 2026-05-22 04573596200865 APERTO Lucent MR-JCR-82 Joint coil (M) MR-JCR-82 for APERTO Lucent/APEROT 2026-05-22 04573596200889 APERTO Lucent MR-JC-81 Joint coil (S) MRJC-81 for APERTO Lucent/APERTO Et 2026-05-22 04573596200896 APERTO Lucent MR-JCR-83 Joint coil (L) MR-JCR-83 for APERTO Lucent/APEROT 2026-05-22 04573596200902 APERTO Lucent MR-CSC-81 C-Spine coil MR-SCS-81 for APERTO Lucent/APERTO Et 2026-05-22 04573596200940 APERTO Lucent MR-QWC-81 Wrist coil MR-QWC-81 for APERTO Lucent/Aperto Eter 2026-05-22 04573596200964 APERTO Lucent MR-MSC-81 Shoulder coil MR-MSC-81 for APERTO Lucent/APERTO E 2026-05-22 04573596200971 APERTO Lucent MR-QRC-81 Head coil (L) MR-QRC-81 for APERTO Lucent/APERTO E 2026-05-22
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