Foot Switch, Autolith Touch 72-00323-0

GUDID 00817183020479

Foot switch for use with Autolith Touch Lithotripter, BSC

NORTHGATE TECHNOLOGIES INC.

Electrohydraulic lithotripsy system
Primary Device ID00817183020479
NIH Device Record Key84a87525-c466-4a56-8e78-7c8cd0c9cd85
Commercial Distribution StatusIn Commercial Distribution
Brand NameFoot Switch, Autolith Touch
Version Model NumberM00546760
Catalog Number72-00323-0
Company DUNS627969264
Company NameNORTHGATE TECHNOLOGIES INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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
GS100817183020479 [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 Date2017-10-23

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