Home GUDID 00854732006027
UreTron Flex Hand Piece
Primary DI 00854732006027
Brand UreTron Flex Hand Piece
Company Ultratellege USA Co., Ltd.
Model URT-TF
Device description UreTron Flex Hand piece for Flex and Semi Flex Probes
Published 2016-09-01
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 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 00854732006027 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 00854732006027 00854732006027 854732006027 0854732006027
GMDN Terms# Term, Definition table Term Definition Ultrasonic lithotripsy system handpiece A hand-held ultrasonic device that creates a high frequency vibration through a transducer, when electrical energy is applied to its piezo-ceramic elements, which is transmitted to stones (calculi) via a coaxially attached metal probe, fragmenting the stones. The electrical energy is supplied and regulated by an ultrasonic lithotripsy generator. The stone fragments are removed through the lumen of the probe and transducer by a suction system which is facilitated through the ultrasonic lithotripsy system. This is a reusable device.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 118825182 Device count 1 Serial number true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00854732006034 UreTron Rigid Sterile Probe 3.1 x 370mm URT-PR-3.1-370S 2016-09-01 00854732006041 UreTron Rigid Sterile Probe 3.5 x 370 mm URT-PR-3.5-370S 2016-09-01 00854732006058 UreTron Rigid Sterile Probe 3.5 x 430mm URT-PR-3.5-430S 2016-09-01 00854732006065 UreTron Rigid Sterile Probe 3.1 x 430 mm URT-PR-3.1-430S 2016-09-01 00854732006072 UreTron Semi Rigid Sterile Probe 1.9 x 370 mm URT-PS-1.9-370S 2016-09-01 00854732006089 UreTron Semi Rigid Sterile Probe 1.9 x 570 mm URT-PS-1.9-570S 2016-09-01 00854732006096 UreTron Semi Rigid Sterile Probe 1.5 x 270 mm URT-PS-1.5-270S 2016-09-01 00854732006102 UreTron Semi Rigid Sterile Probe 1.5 x 370 mm URT-PS-1.5-370S 2016-09-01 00854732006119 UreTron Semi Rigid Sterile Probe 1.5 x 480 mm URT-PS-1.5-480S 2016-09-01 00854732006126 UreTron Semi Rigid Sterile Probe 1.5 x 570 mm URT-PS-1.5-570S 2016-09-01 00854732006140 UreTron Semi Rigid Sterile Probe 1.3 x 370 mm URT-PS-1.3-370S 2016-09-01 00854732006157 UreTron Semi Rigid Sterile Probe 1.3 x 570mm URT-PS-1.3-570S 2016-09-01 00854732006164 UreTron Semi Rigid Sterile Probe 1.0 x 270 mm URT-PS-1.0-270S 2016-09-01 00854732006171 UreTron Semi Rigid Sterile Probe 1.0 x 480 mm URT-PS-1.0-480S 2016-09-01 00854732006188 UreTron Semi Rigid Sterile Probe 1.0 x 570 mm URT-PS-1.0-570S 2016-09-01 00854732006195 UreTron Flexible Sterile Probe 0.8 x 600 mm URT-PF-0.8-600S 2016-09-12 00854732006201 UreTron Flexible Sterile Probe 0.8 x 1200 mm URT-PF-0.8-1200S 2016-09-12 00854732006294 UreTron Flexible Sterile Probe URT-PF-0.8-1370S 2016-09-12 00854732006300 UreTron Flexible Sterile Probe URT-PF-0.8-920S 2016-09-12 00854732006003 UreTron Generator URT-G-US 2016-09-01
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