Home GUDID 04961333254620 PENTAX Medical
Primary DI 04961333254620
Brand PENTAX Medical
Company HOYA CORPORATION
Model OE-B17
Device description PENTAX Medical R/L Assistant Knob OE-B17
Published 2024-12-13
Public version status Update
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 FDS Gastroscope And Accessories, Flexible/Rigid
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FDF Colonoscope And Accessories, Flexible/Rigid Gastroenterology, Urology 2 FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04961333254620 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04961333254620 04961333254620 4961333254620
GMDN Terms# Term, Definition table Term Definition Device control handling knob, reusable A hand-held manual (non-electronic) attachment in the form of a large, easy-grip knob intended to be attached to the manual control of a medical device (e.g., endoscope) to assist a healthcare professional to operate the device. This is a reusable device.
Sterilization Methods# Method table Method High-level Disinfectant Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 691519705 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 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. FDF 2026-06-18 06959664925645 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-06-18 06959664925676 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-06-18 06959664925676 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-06-18 06959664925584 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664925584 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664925614 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664925614 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664925959 NA Hangzhou AGS MedTech Co., Ltd. FDF 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 06959664925980 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664926017 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664926017 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926048 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664926048 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926314 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664926314 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926345 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664926345 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926376 NA Hangzhou AGS MedTech Co., Ltd. FDF 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 06959664926406 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664926673 NA Hangzhou AGS MedTech Co., Ltd. FDS 2026-04-15 06959664926673 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15 06959664926703 NA Hangzhou AGS MedTech Co., Ltd. FDF 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 06959664926734 NA Hangzhou AGS MedTech Co., Ltd. FDF 2026-04-15