Lithotripsy Probe 1.9FR 375cm DS French

GUDID 00817183020509

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

NORTHGATE TECHNOLOGIES INC.

Electrohydraulic/pneumatic lithotripsy system probe, salivary, single-use
Primary Device ID00817183020509
NIH Device Record Key5ff223c8-63a2-4246-af81-47a28aa2c24a
Commercial Distribution StatusIn Commercial Distribution
Brand NameLithotripsy Probe 1.9FR 375cm DS French
Version Model Number9-195-371DS-F
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
GS100817183020509 [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 Date2017-04-18

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