FloWire Doppler Guide Wire XT 300cm 014 ST

GUDID 00184360000198

VOLCANO CORPORATION

Blood flowmeter catheter, Doppler
Primary Device ID00184360000198
NIH Device Record Keyf7ac1cde-0306-4d3c-8237-1b17c4ad8364
Commercial Distribution StatusIn Commercial Distribution
Brand NameFloWire Doppler Guide Wire XT 300cm 014 ST
Version Model Number1413
Company DUNS135179237
Company NameVOLCANO CORPORATION
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100184360000198 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQXWire, Guide, Catheter

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 Date2016-08-24

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