Home GUDID 14547410425175 FUJIFILM
Primary DI 14547410425175
Brand FUJIFILM
Company FUJIFILM CORPORATION
Model EC-760S-A/L
Device description This product is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. Never use this product for any other purposes.
Published 2023-10-23
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 FDF Colonoscope And Accessories, Flexible/Rigid QTH Endoscopic Light-Projecting Measuring Device
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FDF Colonoscope And Accessories, Flexible/Rigid Gastroenterology, Urology 2 QTH Endoscopic Light-Projecting Measuring Device Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 14547410425175 Package GS1 1 In Commercial Distribution 04547410425178 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 14547410425175 14547410425175 04547410425178 04547410425178 4547410425178
GMDN Terms# Term, Definition table Term Definition Flexible video colonoscope, reusable An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy. Anatomical images are transmitted to a monitor for viewing by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope. This device is commonly used to examine the lining of the colon or to evaluate altered bowel habits, colonic cancer, polyps, diverticular disease, occult or frank blood in stools, or unexplained anaemia. 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 30 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 true 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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