Home GUDID 04048551226193 n.a.
Primary DI 04048551226193
Brand n.a.
Company Karl Storz GmbH & Co. KG
Model 11272VNU
Device description Flexible Video Urethro-Cystoscope
Published 2016-09-23
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 FBO CYSTOURETHROSCOPE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FBO Cystourethroscope Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04048551226193 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04048551226193 04048551226193 4048551226193
GMDN Terms# Term, Definition table Term Definition Flexible video cystourethroscope An endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urethra, including the prostate region. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during an endourologic procedure. 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. It is used for biopsy, removal of small stones, treatment of lesions of the urinary bladder/posterior urethra, or to evaluate bladder control/incontinence. This is a reusable device.
Sterilization Methods# Method table Method Peracetic Acid;Hydrogen Peroxide;Liquid Chemical;Ethylene Oxide
Regulatory Flags# DUNS number 315731430 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 04953170438158 Biopsy Valve OLYMPUS MEDICAL SYSTEMS CORP. FBO 2023-04-22 04953170451980 Luer-Split MAJ-2092 OLYMPUS MEDICAL SYSTEMS CORP. FBO 2022-08-05 04055207066218 E-LINE Richard Wolf GmbH FBO 2020-02-21 04055207066225 E-LINE Richard Wolf GmbH FBO 2020-02-21 04055207066195 E-LINE Richard Wolf GmbH FBO 2020-02-21 04055207066201 E-LINE Richard Wolf GmbH FBO 2020-02-21 04048551327746 n.a. Karl Storz GmbH & Co. KG FBO 2019-02-23 04048551390139 n.a. Karl Storz GmbH & Co. KG FBO 2016-12-22 04048551390160 n.a. Karl Storz GmbH & Co. KG FBO 2016-12-22 04048551390184 n.a. Karl Storz GmbH & Co. KG FBO 2016-12-22 04048551390238 n.a. Karl Storz GmbH & Co. KG FBO 2016-12-22 04048551390146 n.a. Karl Storz GmbH & Co. KG FBO 2016-12-22 04048551390177 n.a. Karl Storz GmbH & Co. KG FBO 2016-12-22 00821925007772 Adapter PK Working Element Gyrus® PK™ SuperPulse™ System Gyrus Acmi, Inc. FBO 2016-10-18 00821925001374 Elite™ Bipolar Baumrucker™ Working Element Gyrus® PK™ Super Pulse Sys Gyrus Acmi, Inc. FBO 2016-10-13 00821925001916 USA Elite System™ Iglesias™ Working Element Gyrus Acmi, Inc. FBO 2016-10-13 00821925001947 Elite™ Bipolar Iglesias™ Working Element Gyrus® PK™ Super Pulse Syste Gyrus Acmi, Inc. FBO 2016-10-13 00821925011229 Elite™ Iglesias™ Bipolar Front-Loading Working Element For Gyrus ACMI Gyrus Acmi, Inc. FBO 2016-10-13 00821925008229 USA Elite System™ Iglesias™ Working Element Gyrus Acmi, Inc. FBO 2016-10-05 00821925008243 Elite™ Bipolar Iglesias™ Working Element Gyrus® PK™ Super Pulse Syste Gyrus Acmi, Inc. FBO 2016-10-05 00821925027275 Elite™ Iglesias™ Bipolar Front-Loading Working Element For Gyrus ACMI Gyrus Acmi, Inc. FBO 2016-10-05 04055207018385 NA Richard Wolf GmbH FBO 2016-09-29 04055207018392 NA Richard Wolf GmbH FBO 2016-09-29 04055207018491 NA Richard Wolf GmbH FBO 2016-09-29 04055207018194 MOXY Richard Wolf GmbH FBO 2016-09-27 04055207018231 GREENLIGHT Richard Wolf GmbH FBO 2016-09-27 04055207018255 GREENLIGHT Richard Wolf GmbH FBO 2016-09-27 04055207018286 E-LINE Richard Wolf GmbH FBO 2016-09-27 04055207018293 E-LINE Richard Wolf GmbH FBO 2016-09-27 04055207019412 E-LINE Richard Wolf GmbH FBO 2016-09-27