Azur Pushable Helical 45-250404

GUDID 10810170012447

Azur

MICROVENTION INC.

Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil Non-neurovascular embolization coil

• Primary Device ID: 10810170012447
• NIH Device Record Key: d123bd2b-25e6-427c-83b7-21066c7dba6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Azur Pushable Helical
• Version Model Number: 45-250404
• Catalog Number: 45-250404
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00810170012440 [Primary]
GS1	10810170012447 [Package]; Contains: 00810170012440; Package: Carton [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071939

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: 2015-12-29

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