Home GUDID 00821925001428 GYRUS ACMI
Primary DI 00821925001428
Brand GYRUS ACMI
Company Gyrus ACMI, LLC
Model CW-USLPC
Device description CYBERWAND POWER CORD
Published 2016-10-13
Public version status Update
Distribution status Not 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 FFK Lithotriptor, electro-hydraulic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00821925001428 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 00821925001428 00821925001428 821925001428 0821925001428
GMDN Terms# Term, Definition table Term Definition Electrohydraulic lithotripsy system An assembly of devices that uses plasma-induced shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder. It typically comprises a generator-powered probe which fires energy pulses at the stone's centre while the probe is irrigated with a saline solution. The collapse of the resulting plasma bubble causes a hydraulic shock that fragments the stone into several pieces which can then be removed using surgical instruments (e.g., a grasping instrument or stone basket).
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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00821925019157 VOCOM 143000 2015-10-24 00821925019164 GYRUS ACMI, INC 143001 2015-10-24 00821925019171 GYRUS ACMI, INC 143002 2015-10-24 00821925019225 GYRUS ACMI, INC 143006 2015-10-24 00821925019232 GYRUS ACMI, INC 143007 2015-10-24 00821925019249 GYRUS ACMI, INC 143008 2015-10-24 00821925019300 GYRUS ACMI, INC 143003 2015-10-24 00821925019317 GYRUS ACMI, INC 143004 2015-10-24 00821925019324 GYRUS ACMI, INC 143005 2015-10-24 00821925012738 EVONOS GMBH & Co. Kg 130015 2018-09-04 00821925012783 EVONOS 130020 2018-09-06 00821925012790 EVONOS 130021-ENT 2018-09-06 00821925012806 EVONOS 130022 2018-09-06 00821925012813 EVONOS 130023 2018-09-06 00821925012820 EVONOS 130024 2018-09-06 00821925012837 Gyrus ACMI 130025-ENT 2018-09-06 00821925012929 EVONOS 130038 2018-09-06 00821925013001 EVONOS 130201 2018-09-10 00821925013018 EVONOS 130202 2018-09-10 00821925013025 EVONOS 130203 2018-09-10
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