Home GUDID 04961333085538 PENTAX
Primary DI 04961333085538
Brand PENTAX
Company HOYA CORPORATION
Model OE-A41
Device description Distal Rubber Tip OE-A41
Published 2023-07-31
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
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 14961333085535 Primary GS1 0 04961333085538 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 14961333085535 14961333085535 04961333085538 04961333085538 4961333085538
GMDN Terms# Term, Definition table Term Definition Endoscope hood A sterile, Hevea-latex, bell-shaped device designed to be placed onto the distal end of an endoscope (e.g., oesophagoscope) to facilitate the removal of a foreign body. The device everts to create a dome around the (sharp) foreign object to protect the wall of the viscus as the endoscope/foreign body is extracted. This is a single-use device.
Sterilization Methods# Method table Method High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 691519705 Device count 20 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06959664925645 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-06-18 06959664925676 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-06-18 06959664925584 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664925614 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664925959 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664925980 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926017 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926048 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926314 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926345 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926376 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926406 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926673 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926703 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926734 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926765 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664927038 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664927069 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664927090 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664927120 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664927403 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664927434 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664927465 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664927496 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664928943 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664928974 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664929001 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664929032 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664929070 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664929100 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15