Azur Detachable Helical HydroCoil 45-480815

GUDID 00810170012617

Azur

MICROVENTION INC.

Non-neurovascular embolization coil
Primary Device ID00810170012617
NIH Device Record Key7848a7bf-c453-4d6c-812b-8c1a539f173d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAzur Detachable Helical HydroCoil
Version Model Number45-480815
Catalog Number45-480815
Company DUNS003263105
Company NameMICROVENTION INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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 Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com
Phone+1(714)247-8000
Emailcustomerservice@microvention.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100810170012617 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRDDevice, Vascular, for Promoting Embolization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-19
Device Publish Date2015-12-29

On-Brand Devices [Azur Detachable Helical HydroCoil]

00810170018084Azur
00810170018077Azur
00810170018060Azur
00810170018053Azur
00810170018046Azur
00810170018039Azur
00810170018022Azur
00810170018015Azur
00810170018008Azur
00810170017995Azur
00810170017988Azur
00810170017971Azur
00810170017964Azur
00810170017957Azur
00810170017940Azur
00810170017933Azur
00810170017926Azur
00810170017919Azur
00810170017902Azur
00810170017896Azur
00810170017889Azur
00810170017872Azur
00810170017865Azur
00810170017858Azur
00810170017841Azur
00810170016400Azur
00810170016394Azur
00810170016387Azur
00810170015045Azur
00810170015038Azur
00810170015021Azur
00810170015014Azur
00810170015007Azur
00810170014994Azur
00810170014987Azur
00810170014970Azur
00810170014963Azur
00810170014956Azur
00810170014949Azur
00810170014932Azur
00810170014925Azur
00810170014918Azur
00810170014901Azur
00810170014895Azur
00810170014888Azur
00810170014390Azur
00810170014383Azur
00810170014376Azur
00810170014369Azur
00810170013867Azur

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