Home GUDID 04961333232642 VIDEO SIGMOIDOSCOPE
Primary DI 04961333232642
Brand VIDEO SIGMOIDOSCOPE
Company PENTAX OF AMERICA, INC.
Model ES-3870K
Device description VIDEO SIGMOIDOSCOPE 4.2C 12.8T 700L FWJ (REFURBISHED)
Published 2017-04-06
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 FAM Sigmoidoscope And Accessories, Flexible/Rigid
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FAM Sigmoidoscope And Accessories, Flexible/Rigid Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04961333232642 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04961333232642 04961333232642 4961333232642
GMDN Terms# Term, Definition table Term Definition Flexible video gastroscope, reusable An endoscope with a flexible inserted portion intended for the visual examination and/or treatment of the oesophagus and/or stomach. It is inserted through the mouth and images are transmitted by a video system with an image sensor chip at the distal end of the endoscope and images displayed on a monitor; it may also be used to obtain biopsies or perform other procedures. This is a reusable device.
Sterilization Methods# Method table Method Ethylene Oxide High-level Disinfectant
Regulatory Flags# DUNS number 083211284 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 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 00732094139051 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2023-08-18 00732094139075 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2023-08-18 00732094080940 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2023-08-17 00732094080957 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2023-08-17 00732094080964 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2023-08-17 04961333115303 PENTAX HOYA CORPORATION FAM 2023-07-31 04547410436501 FUJIFILM FUJIFILM CORPORATION FAM 2021-04-27 00732094080384 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2021-04-26 00732094080391 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2021-04-14 00732094200300 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2020-01-16 00732094079678 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2018-03-01 00732094080933 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2018-03-01 04961333070831 PENTAX HOYA CORPORATION FAM 2017-04-07 04961333071425 PENTAX HOYA CORPORATION FAM 2017-04-07 04961333228164 PENTAX HOYA CORPORATION FAM 2017-04-07 04961333232635 VIDEO SIGMOIDOSCOPE PENTAX OF AMERICA, INC. FAM 2017-04-06 04547410330977 FUJIFILM FUJIFILM CORPORATION FAM 2016-12-14 04547410333299 FUJIFILM FUJIFILM CORPORATION FAM 2016-12-14 04048551084373 n.a. Karl Storz GmbH & Co. KG FAM 2016-09-23 00732094236958 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2016-09-20 00732094144024 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2016-09-20 00732094106046 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2016-09-19 00732094106060 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2016-09-17 00732094144000 Welch Allyn, Inc. WELCH ALLYN, INC. FAM 2016-09-17 00749756173520 DeRoyal DEROYAL INDUSTRIES, INC. FAM 2016-09-12 50749756173525 DeRoyal DEROYAL INDUSTRIES, INC. FAM 2016-09-12