Traxcess SELECT GW1420040S

GUDID 00812636022260

Guidewires

MICROVENTION INC.

Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use
Primary Device ID00812636022260
NIH Device Record Key19af1254-8b1c-4b20-a0f4-cd09a4657758
Commercial Distribution StatusIn Commercial Distribution
Brand NameTraxcess SELECT
Version Model NumberGW1420040S
Catalog NumberGW1420040S
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100812636022260 [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 Number2
Public Version Date2018-11-21
Device Publish Date2018-08-07

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