Helical Regular 18 Advanced 8618-0730

GUDID 00812636023045

V-Trak

MICROVENTION INC.

Neurovascular embolization coil

• Primary Device ID: 00812636023045
• NIH Device Record Key: 07547c68-8ea1-449e-8d11-39d3b1a8b969
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Helical Regular 18 Advanced
• Version Model Number: 8618-0730-A1
• Catalog Number: 8618-0730
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• Phone: +1(714)247-8000
• Email: customerservice@microvention.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812636023045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132952

FDA Product Code

• KRD: Device, Vascular, for Promoting Embolization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-19
• Device Publish Date: 2016-09-24

On-Brand Devices [Helical Regular 18 Advanced]

• 00812636023120: V-Trak
• 00812636023113: V-Trak
• 00812636023106: V-Trak
• 00812636023090: V-Trak
• 00812636023083: V-Trak
• 00812636023076: V-Trak
• 00812636023069: V-Trak
• 00812636023052: V-Trak
• 00812636023045: V-Trak
• 00812636023038: V-Trak
• 00812636023014: V-Trak
• 00811425028568: V-Trak
• 00811425028551: V-Trak
• 00811425028544: V-Trak
• 00811425028537: V-Trak
• 00811425028520: V-Trak
• 00811425028513: V-Trak
• 00811425028506: V-Trak
• 00811425028490: V-Trak
• 00811425028483: V-Trak
• 00811425028476: V-Trak
• 00811425028469: V-Trak