Home GUDID 00854732006041 UreTron Rigid Sterile Probe 3.5 x 370 mm
Primary DI 00854732006041
Brand UreTron Rigid Sterile Probe 3.5 x 370 mm
Company Ultratellege USA Co., Ltd.
Model URT-PR-3.5-370S
Device description UreTron Rigid Sterile Probe 3.5 x 370 mm
Published 2016-09-01
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 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 00854732006041 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 00854732006041 00854732006041 854732006041 0854732006041
GMDN Terms# Term, Definition table Term Definition Ultrasonic lithotripsy system reusable A slender, metal, tubular device that is coaxially attached to an ultrasonic lithotripsy system handpiece [a hand-held acoustic transducer that produces ultrasound (US) waves] and intended to transmit US waves to calculi (stones) in the urinary tract (i.e., kidneys, ureters, and bladder) for their fragmentation. Its distal end is brought into contact with calculi and transmits the energy, breaking down the calculi in the body for removal through its lumen. This device is introduced through the working channel of an appropriate endoscope (e.g., a percutaneous nephroscope for ureteral stones). This is a reusable device intended to be sterilized prior to use.
Regulatory Flags# DUNS number 118825182 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label 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 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 00854732006010 UreTron Rigid Hand Piece URT-TR 2016-09-01
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