Autolith 100V

GUDID 00817183020400

Lithotripter

NORTHGATE TECHNOLOGIES INC.

Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system
Primary Device ID00817183020400
NIH Device Record Keyc29b90f1-c568-41e8-a581-bdbccca325c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutolith 100V
Version Model Number9-201-01
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 Usetrue
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
GS100817183020394 [Primary]
GS100817183020400 [Package]
Contains: 00817183020394
Package: [1 Units]
In Commercial Distribution

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 Date2016-10-14

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