Home GUDID 00821925002418 USA Elite
Primary DI 00821925002418
Brand USA Elite
Company Gyrus ACMI, LLC
Model E125-S
Device description USA Elite System Cystourethroscope Sheath 25 Fr, (8.3 mm) Color Coded Green
Published 2016-10-13
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 FEC OBTURATOR, FOR ENDOSCOPE HIH Hysteroscope (And Accessories)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FEC Obturator, For Endoscope Gastroenterology, Urology 2 HIH Hysteroscope (And Accessories) Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00821925002418 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 00821925002418 00821925002418 821925002418 0821925002418
GMDN Terms# Term, Definition table Term Definition Rigid cystourethroscope An endoscope with a rigid 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 the device through relayed lens optics or a fibreoptic bundle. This device is commonly used for biopsy, removal of concretions (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 Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 007198742 Device count 1 Lot or batch true Manufacturing date on label 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 06974880994053 Manual Tissue Removal Device Suzhou AcuVu medical technology Co., Ltd. HIH 2026-07-27 06974880994084 Manual Tissue Removal Device Suzhou AcuVu medical technology Co., Ltd. HIH 2026-07-27 06975339623418 SeleneView® MacroLux Medical Technology Co., Ltd. HIH 2026-07-03 00821925002104 USA Elite System Gyrus ACMI, LLC HIH 2024-11-21 00821925002074 USA Elite System Gyrus ACMI, LLC HIH 2024-07-25 00821925002562 SlimLine Gyrus ACMI, LLC HIH 2024-07-24 07613327616675 SPY STRYKER CORPORATION HIH 2024-02-27 07613327616682 SPY STRYKER CORPORATION HIH 2024-02-27 07613327616699 SPY STRYKER CORPORATION HIH 2024-02-27 07613327616705 SPY STRYKER CORPORATION HIH 2024-02-27 07613327616712 SPY STRYKER CORPORATION HIH 2024-02-27 07613327616729 SPY STRYKER CORPORATION HIH 2024-02-27 07613327616736 SPY STRYKER CORPORATION HIH 2024-02-27 07613327616743 SPY STRYKER CORPORATION HIH 2024-02-27 07613327624311 NA STRYKER CORPORATION HIH 2024-02-27 07613327507102 N/A STRYKER SUSTAINABILITY SOLUTIONS, INC. HIH 2020-10-26 07613327507119 N/A STRYKER SUSTAINABILITY SOLUTIONS, INC. HIH 2020-10-26 07613327507126 N/A STRYKER SUSTAINABILITY SOLUTIONS, INC. HIH 2020-10-26 07613327507133 N/A STRYKER SUSTAINABILITY SOLUTIONS, INC. HIH 2020-10-26 07613327507140 N/A STRYKER SUSTAINABILITY SOLUTIONS, INC. HIH 2020-10-26 08714729986935 Cytuity™ BOSTON SCIENTIFIC CORPORATION HIH 2019-08-20 10884521750203 TruClear Covidien LP HIH 2018-12-21 00821925004986 Gyrus ACMI Gyrus ACMI, LLC HIH 2018-09-13 10884521744080 TruClear Covidien LP HIH 2017-10-16 10884521744097 TruClear Covidien LP HIH 2017-10-16 10884521744103 TruClear Covidien LP HIH 2017-10-16 10884521744110 TruClear Covidien LP HIH 2017-10-16 M648C0100110 SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ GYN OBP CORPORATION HIH 2016-11-11 M648C0100120 SELF SEALING SEAL 1 SIZE FITS ALL FOR KARL STORZ URO OBP CORPORATION HIH 2016-11-11 00821925001862 USA Series Gyrus ACMI, LLC HIH 2016-10-14