Lithotripsy Probe 9FR 54cm

GUDID 10817183020179

9FR 54cm Lithotripsy Probe for use with Autolith Lithotripters

NORTHGATE TECHNOLOGIES INC.

Electrohydraulic/pneumatic lithotripsy system probe, urinary, single-use Electrohydraulic/pneumatic lithotripsy system probe, urinary, single-use Electrohydraulic/pneumatic lithotripsy system probe, urinary, single-use
Primary Device ID10817183020179
NIH Device Record Keyfc64fbcd-2ddb-4e0c-9901-43ba44b5ee12
Commercial Distribution StatusIn Commercial Distribution
Brand NameLithotripsy Probe 9FR 54cm
Version Model Number9-900-54
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
GS100817183020172 [Primary]
GS110817183020179 [Package]
Contains: 00817183020172
Package: [3 Units]
In Commercial Distribution

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 9FR 54cm]

108171830201799FR 54cm Lithotripsy Probe for use with Autolith Lithotripters
008171830201109FR 54cm Lithotripsy Probe for use with Autolith Uro-Touch Lithotripters

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