Traxcess 7 Mini Xsoft GW0721006S

GUDID 00816777025500

Guidewires

MICROVENTION INC.

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 00816777025500
• NIH Device Record Key: 11b5a7d3-ed68-448f-9878-f922feefa91c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Traxcess 7 Mini Xsoft
• Version Model Number: GW0721006S
• Catalog Number: GW0721006S
• 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	00816777025500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163154

FDA Product Code

• MOF: GUIDE, WIRE, CATHETER, NEUROVASCULATURE

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-07
• Device Publish Date: 2018-08-07

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