Home GUDID 04547410074093 FUJIFILM
Primary DI 04547410074093
Brand FUJIFILM
Company FUJIFILM CORPORATION
Model DH-17EN
Device description This product is the hood for observation assistance used in combination with our endoscopes in medical facilities.
Published 2016-09-16
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name FDA Enteroscope and accessories FDF Colonoscope And Accessories, Flexible/Rigid
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FDA Enteroscope And Accessories Gastroenterology, Urology 2 FDF Colonoscope And Accessories, Flexible/Rigid Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04547410074093 Primary GS1 0 84547410074099 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04547410074093 04547410074093 4547410074093 84547410074099 84547410074099
GMDN Terms# Term, Definition table Term Definition Endoscope tissue removal cap A plastic tube designed to be placed onto the distal end of an endoscope (e.g., oesophagoscope) to facilitate the removal of coagulated blood/tissue from the path of the endoscope during endoscopic surgery. It is designed to fit tightly without fixing, having an oblique leading edge that extends beyond the end of the endoscope to provide atraumatic penetration and tissue removal functionality (e.g., scooping, grasping). This is a single-use 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 10 Degrees Celsius 40 Degrees Celsius
Sterilization Methods# Method table Method "[""High-level Disinfectant"", ""Moist Heat or Steam Sterilization"", ""Ethylene Oxide""]" High-level Disinfectant;Moist Heat or Steam Sterilization;Ethylene Oxide
Regulatory Flags# DUNS number 713565195 Device count 10 Lot or batch true Expiration date on label true 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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