Traxcess Guidewire GW1420040

GUDID 00811425020340

Guidewires

MICROVENTION INC.

Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 00811425020340
• NIH Device Record Key: cd7ee250-8f28-4289-99a4-c401076eba5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Traxcess Guidewire
• Version Model Number: GW1420040-A
• Catalog Number: GW1420040
• Company DUNS: 003263105
• Company Name: MICROVENTION INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811425020340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080863

FDA Product Code

• DQX: WIRE, GUIDE, CATHETER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-11-23
• Device Publish Date: 2016-09-24

On-Brand Devices [Traxcess Guidewire]

• 00811425021330: Guidewires
• 00811425020340: Guidewires
• 00810170012280: Guidewires
• 00812636020006: Guidewires