Home GUDID 14547410532873 FUJIFILM
Primary DI 14547410532873
Brand FUJIFILM
Company FUJIFILM CORPORATION
Model DH-083ST
Device description This hood is intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
Published 2024-12-20
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use 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 14547410532873 Package GS1 5 In Commercial Distribution 04547410532876 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 14547410532873 14547410532873 04547410532876 04547410532876 4547410532876
GMDN Terms# Term, Definition table Term Definition Endoscope tissue removal cap, single-use 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 no dew condensation. Stored in package box. Storage Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature -20 Degrees Celsius 60 Degrees Celsius
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 true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false 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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