Home GUDID 00821925003187 USA Elite
Primary DI 00821925003187
Brand USA Elite
Company Gyrus ACMI, LLC
Model ESCR
Device description USA Elite System Cysto-Resectoscope Spacer Use With USA Elite System Short Bridge, Rigid Forceps And Resectoscope Sheaths
Published 2016-10-14
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 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 00821925003187 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 00821925003187 00821925003187 821925003187 0821925003187
GMDN Terms# Term, Definition table Term Definition Rigid endoscopic stone-retrieval forceps, reusable A rigid manual device intended to be inserted through the working channel of a compatible endoscope to grasp and remove stones (e.g., calculi from the urinary tract) or foreign bodies during an endoscopic procedure. It is typically a very long instrument with one sliding and one stationary rod, or a sheath, whose distal ends are equipped with thin grasping claws in which the stone is seized and held for extraction. The claws are typically operated by scissors-like ring handles at the proximal end of the instrument. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 007198742 Device count 1 Premarket exempt true 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 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 00821925001268 USA Elite Gyrus ACMI, LLC FGO 2016-10-13 00821925009509 GYRUS ACMI Gyrus ACMI, LLC FGO 2016-10-12 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