Traxcess 7 Mini Xsoft GW0721006S

GUDID 00816777025500

Guidewires

MICROVENTION INC.

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID00816777025500
NIH Device Record Key11b5a7d3-ed68-448f-9878-f922feefa91c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTraxcess 7 Mini Xsoft
Version Model NumberGW0721006S
Catalog NumberGW0721006S
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

Device Dimensions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100816777025500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MOFGUIDE, WIRE, CATHETER, NEUROVASCULATURE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-07
Device Publish Date2018-08-07

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