Mi-Axus Catheter

GUDID B293MIA9095S0

The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft catheter designed for use in facilitating the insertion and guidanc

MIVI NEUROVASCULAR

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Primary Device IDB293MIA9095S0
NIH Device Record Keyf9bd2ebd-ba09-4b84-b208-f3be4fee962c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMi-Axus Catheter
Version Model NumberMIA9095S
Company DUNS076836823
Company NameMIVI NEUROVASCULAR
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French
Length95 Centimeter
Catheter Gauge8 French

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB293MIA9095S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCatheter, Percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-01-23
Device Publish Date2018-02-23

On-Brand Devices [Mi-Axus Catheter]

B293MIA9095S0The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft catheter desi
B293MIA9090S0The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft catheter desi
B293MIA90900The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft catheter desi
B293MIA9080S0The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft catheter desi
B293MIA90800The Mi-Axus 8F Guide Catheter is a single lumen, braided, variable stiffness shaft catheter desi
B293MIA571300The Mi-Axus 6F Distal Access Catheter is a single lumen, braided shaft, variable stiffness cathe
B293MIA571120The Mi-Axus 6F Distal Access Catheter is a single lumen, braided shaft, variable stiffness cathe

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