Lithotripsy Probe 1.9FR 375cm DS

GUDID 00817183020448

1.9FR 375cm DS Lithotripsy Probe for use with Autolith Touch Lithotripters, BSC

NORTHGATE TECHNOLOGIES INC.

Electrohydraulic/pneumatic lithotripsy system probe, salivary, single-use
Primary Device ID00817183020448
NIH Device Record Keyec94b682-a5a1-41cd-b17c-5a09b6f3ef68
Commercial Distribution StatusIn Commercial Distribution
Brand NameLithotripsy Probe 1.9FR 375cm DS
Version Model NumberM00546620
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817183020448 [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 Date2017-02-09

On-Brand Devices [Lithotripsy Probe 1.9FR 375cm DS]

008171830204481.9FR 375cm DS Lithotripsy Probe for use with Autolith Touch Lithotripters, BSC
008171830201581.9FR 375cm DS Lithotripsy Probe for use with Autolith Lithotripters
008171830200731.9FR 375cm DS Lithotripsy Probe for use with Autolith Touch Lithotripters

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