Traxcess 7 Mini GW0721006M

GUDID 00816777025494

Guidewires

MICROVENTION INC.

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID00816777025494
NIH Device Record Key5fe1d0e5-8808-419c-9521-20ca01b1e5b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameTraxcess 7 Mini
Version Model NumberGW0721006M
Catalog NumberGW0721006M
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
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 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
GS100816777025494 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-07
Device Publish Date2018-08-07

Devices Manufactured by MICROVENTION INC.

00842429108444 - Sofia2024-10-28 Sofia 6F-115cm STR
00842429108451 - Sofia2024-10-28 Sofia 6F-125cm STR
00842429108468 - Sofia2024-10-28 Sofia 6F-131cm STR
00842429108475 - Sofia2024-10-28 Sofia 6F-125cm STR
00842429118092 - Access2024-10-28 Sofia EX 5F - 115cm STR
00842429119396 - Wedge2024-10-28 Wedge XL
00842429108482 - Sofia2024-08-14 Sofia 6F-131cm STR
00842429117705 - SOFIA 882023-06-23 SOFIA 88 - 115cm

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.