Home GUDID 50749756173525
DeRoyal
Primary DI 50749756173525
Brand DeRoyal
Company DEROYAL INDUSTRIES, INC.
Model 32-898
Device description CUSTOM SIGMOIDOSCOPE
Published 2016-09-12
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile true
Single use true
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 50749756173525 Package GS1 50 In Commercial Distribution 00749756173520 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 50749756173525 50749756173525 00749756173520 00749756173520 749756173520 0749756173520
GMDN Terms# Term, Definition table Term Definition Flexible video sigmoidoscope An endoscope with a flexible inserted portion intended for the visual examination and treatment of the sigmoid colon (the distal S-shaped part of the large intestine leading to the rectum). It is inserted through the anus during sigmoidoscopy or proctosigmoidoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. This device is commonly used to examine the structures and lining of the sigmoid colon and for indications of altered bowel habit, colonic cancer, or polyps. This is a reusable device.
Regulatory Flags# DUNS number 096372255 Device count 1 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 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# 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 04961333232642 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