Home GUDID 00821925009509 GYRUS ACMI
Primary DI 00821925009509
Brand GYRUS ACMI
Company Gyrus ACMI, LLC
Model 5700002
Device description SURLOK Helical Stone Basket 1.9 FR (0.6 mm) X 120 cm Basket Width: 10 mm # of Wires: 3
Published 2016-10-12
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name FGO DISLODGER, STONE, FLEXIBLE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FGO Dislodger, Stone, Flexible Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00821925009509 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 00821925009509 00821925009509 821925009509 0821925009509
GMDN Terms# Term, Definition table Term Definition Urinary stone retrieval basket, single-use A manual endotherapy instrument designed to be inserted through the working channel of an endoscope to trap, retrieve, and/or manipulate urinary stones for the treatment of conditions such as nephrolithiasis and urolithiasis (i.e., presence of calculi in the kidneys or urinary tract). It typically consists of a flexible sheath with a braided self-expanding basket [typically made of nickel-titanium alloy (Nitinol)] at the distal end. A handle located at the proximal end of the instrument is designed to open, close, and rotate the basket. The device is used with a nephroscope or ureteroscope during urological and related procedures. This is a single-use device.
Regulatory Flags# DUNS number 007198742 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00821925044326 SOLTIVE Gyrus ACMI, LLC FGO 2020-03-23 00724995182663 Falcon US Endoscopy FGO 2020-03-19 00724995182786 Talon US Endoscopy FGO 2020-03-19 10724995182660 Falcon US Endoscopy FGO 2020-03-19 10724995182783 Talon US Endoscopy FGO 2020-03-19 00810116022304 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2020-02-18 00810116022311 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2020-02-18 00810116022328 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2020-02-18 00810116022335 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2020-02-18 00810116022342 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2020-02-18 00810116022359 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2020-02-18 00810116022366 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2020-02-18 00810116022373 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2020-02-18 00810116022908 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2020-02-18 00810116022915 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2020-02-18 00821925041349 OLYMPUS Gyrus ACMI, LLC FGO 2020-01-28 00810116020577 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2018-12-04 00810116020584 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2018-12-04 00810116020591 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2018-12-04 00810116020638 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2018-12-04 00810116020645 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2018-12-04 00810116020652 Dornier MedTech DORNIER MEDTECH AMERICA, INC. FGO 2018-12-04 00821925007468 Gyrus ACMI Gyrus ACMI, LLC FGO 2016-10-18 00821925007956 Gyrus ICMI Gyrus ACMI, LLC FGO 2016-10-18 00821925003187 USA Elite Gyrus ACMI, LLC FGO 2016-10-14 00821925001268 USA Elite Gyrus ACMI, LLC FGO 2016-10-13 00821925010673 GYRUS ACMI Gyrus ACMI, LLC FGO 2016-10-12 00821925027688 OLYMPUS Gyrus ACMI, LLC FGO 2016-10-05 00821925027695 OLYMPUS Gyrus ACMI, LLC FGO 2016-10-05 00821925027701 OLYMPUS Gyrus ACMI, LLC FGO 2016-10-05