Autolith Touch

GUDID 00817183020554

Lithotripter, Biliary, BSC, Hospital Owned

NORTHGATE TECHNOLOGIES INC.

Electrohydraulic lithotripsy system
Primary Device ID00817183020554
NIH Device Record Keyff16d91f-7332-465a-8645-8a2d0585ba9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutolith Touch
Version Model NumberM0054668H0
Company DUNS627969264
Company NameNORTHGATE TECHNOLOGIES INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817183020554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FFKLithotriptor, Electro-Hydraulic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-03-10

On-Brand Devices [Autolith Touch]

00817183020561Lithotripter, Biliary, BSC, Zero Cost Refurbished
00817183020554Lithotripter, Biliary, BSC, Hospital Owned
00817183020547Lithotripter, Biliary, BSC, Loaner
00817183020530Lithotripter, Biliary, BSC, Demo
00817183020523Lithotripter, Biliary, BSC, Refurbished
00817183020493Lithotripter, Biliary, BSC
00817183020004Lithotripter

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