Home GUDID 00821925007772 Adapter PK Working Element Gyrus® PK™ SuperPulse™ System
Primary DI 00821925007772
Brand Adapter PK Working Element Gyrus® PK™ SuperPulse™ System
Company Gyrus Acmi, Inc.
Model PKWE-AD
Published 2016-10-18
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 00821925007772 Package GS1 5 In Commercial Distribution 00821925038547 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 00821925007772 00821925007772 821925007772 0821925007772 00821925038547 00821925038547 821925038547 0821925038547
GMDN Terms# Term, Definition table Term Definition Resectoscope An endoscope with a slender rigid inserted portion intended to be used to perform a resection (i.e., the electrosurgical removal of tissue within an organ). It is typically used for the transurethral resection of the prostate (TURP) for the treatment of benign prostatic hyperplasia (BPH) and removal of, e.g., myomas (fibroids) and polyps in the uterine cavity via the cervix. It typically consists of an outer sheath, a wide angle telescope, a working guide element and a variety of interchangeable electrosurgical electrodes such as a wire loop, knife, roller ball, ball and coagulating. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 007198742 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true 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 04048438000175 NA Karl Storz GmbH & Co. KG FBO 2025-03-27 04048551431382 n.a. Karl Storz GmbH & Co. KG FBO 2024-11-28 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 00821925038547 Gyrus ACMI Gyrus ACMI, LLC FBO 2016-10-18 00821925001374 Gyrus ACMI Gyrus ACMI, LLC FBO 2016-10-13 00821925001916 USA Elite Gyrus ACMI, LLC FBO 2016-10-13 00821925001947 Elite Bipolar Gyrus ACMI, LLC FBO 2016-10-13 00821925011229 Elite Iglesias Gyrus ACMI, LLC FBO 2016-10-13 00821925008229 USA Elite Gyrus ACMI, LLC FBO 2016-10-05 00821925008243 Elite Gyrus ACMI, LLC FBO 2016-10-05 00821925027275 Gyrus ACMI Gyrus ACMI, LLC 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