Home GUDID 00848657020879 AED
Primary DI 00848657020879
Brand AED
Company NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model 32-4387
Device description Hook shape knife for optical urethr
Published 2017-11-28
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name EZO Urethrotome
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EZO Urethrotome Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00848657020879 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 00848657020879 00848657020879 848657020879 0848657020879
GMDN Terms# Term, Definition table Term Definition Urethrotome A surgical instrument designed like a long catheter or thin flexible endoscope shape with a lateral moveable small knife at the distal end which is used for incising strictures in the urethra, (the duct by which urine is discharged from the bladder). This operation may be performed either "blind", where the surgeon cannot see the site, or with the help of endoscopic instruments. Some device designs may incorporate an optical channel for endoscopic visual control. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 839138955 Device count 1 Premarket exempt true Lot or batch true Serial number true 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 04048551232378 n.a. Karl Storz GmbH & Co. KG EZO 2025-08-11 04048551232781 n.a. Karl Storz GmbH & Co. KG EZO 2025-08-11 00810143891263 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. EZO 2024-09-27 00810143890914 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. EZO 2024-04-15 00850033250756 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. EZO 2022-06-08 00850033250886 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. EZO 2022-06-08 00850033250893 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. EZO 2022-06-08 00850033250909 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. EZO 2022-06-08 00850033250916 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. EZO 2022-06-08 00850033250923 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. EZO 2022-06-08 00190776156718 Millennium Avalign Technologies, Inc. EZO 2020-11-25 00848657076494 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. EZO 2019-06-14 00848657085083 AED NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. EZO 2019-06-14 00842331119019 Novo Surgical NOVO SURGICAL, INC. EZO 2019-05-06 00842331119026 Novo Surgical NOVO SURGICAL, INC. EZO 2019-05-06 00842331119033 Novo Surgical NOVO SURGICAL, INC. EZO 2019-05-06 00842331119040 Novo Surgical NOVO SURGICAL, INC. EZO 2019-05-06 00842331119057 Novo Surgical NOVO SURGICAL, INC. EZO 2019-05-06 00842331119064 Novo Surgical NOVO SURGICAL, INC. EZO 2019-05-06 04046826063023 Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft EZO 2018-11-13 04046826063030 Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft EZO 2018-11-13 04046826063047 Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft EZO 2018-11-13 04048551233986 n.a. Karl Storz GmbH & Co. KG EZO 2018-09-04 04059082029757 Urethrotomy sheath SOPRO-COMEG GmbH EZO 2018-03-20 04059082029764 Obturator SOPRO-COMEG GmbH EZO 2018-03-20 04059082029771 Urethrotomy tube SOPRO-COMEG GmbH EZO 2018-03-20 04059082029788 Urethrotomy bridge SOPRO-COMEG GmbH EZO 2018-03-20 04059082029795 Urethrotomy knife SOPRO-COMEG GmbH EZO 2018-03-20 04059082029801 Urethrotomy knife SOPRO-COMEG GmbH EZO 2018-03-20 04059082029818 Urethrotomy sheath SOPRO-COMEG GmbH EZO 2018-03-20