Lithotripsy Probe 1.9FR 250cm

GUDID 00817183020059

1.9FR 250cm Lithotripsy Probe for use with Autolith Touch Lithotripters

NORTHGATE TECHNOLOGIES INC.

Electrohydraulic/pneumatic lithotripsy system probe, salivary, single-use
Primary Device ID00817183020059
NIH Device Record Key527f1556-d159-4a5d-bc97-99e8cc5efac3
Commercial Distribution StatusIn Commercial Distribution
Brand NameLithotripsy Probe 1.9FR 250cm
Version Model Number9-202-2501
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817183020059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FFKLithotriptor, Electro-Hydraulic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-13

On-Brand Devices [Lithotripsy Probe 1.9FR 250cm]

008171830201341.9FR 250cm Lithotripsy Probe for use with Autolith Lithotripters
008171830200591.9FR 250cm Lithotripsy Probe for use with Autolith Touch Lithotripters

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