Extender Cable, Autolith Touch

GUDID 00817183020455

Extender cable for use with Autolith Touch Lithotripter, BSC

NORTHGATE TECHNOLOGIES INC.

Electrohydraulic lithotripsy system
Primary Device ID00817183020455
NIH Device Record Keydd934318-139d-4a36-812f-62c914d28010
Commercial Distribution StatusIn Commercial Distribution
Brand NameExtender Cable, Autolith Touch
Version Model NumberM00546750
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817183020455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FFKLithotriptor, Electro-Hydraulic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817183020455]

Moist Heat or Steam Sterilization


[00817183020455]

Moist Heat or Steam Sterilization


[00817183020455]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-09

Devices Manufactured by NORTHGATE TECHNOLOGIES INC.

00817183020820 - StimSite AM-VY1 Adapter2024-07-18 StimSite Voyant Adapter
10817183020810 - PUREPNEUMO Tubing Set2024-07-17 Paired Insufflation and TAP Tubing
00817183020769 - StimSite Signal Box2024-05-07
00817183020776 - StimSite Activation Card2023-11-29 Activation Card, StimSite, Single
00817183020660 - NEBULAE SRS Tubing Set2023-02-22
00817183020684 - NEBULAE SRS Laparoscopic Surgical Pump2023-02-22
00817183020745 - Smith & Nephew Insufflator 5002021-01-14 Insufflator, Laparoscopic, S&N 500 Service Replacement, 50LPM
10817183020605 - TAP2021-01-13 Insufflation Tubing, True Abdominal Pressure Sensing

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.