HydroFrame 18 Advanced 7118-1445

GUDID 00812636024400

V-Trak

MICROVENTION INC.

Neurovascular embolization coil

• Primary Device ID: 00812636024400
• NIH Device Record Key: 2955dc4b-a16b-45b3-a8df-101b1e52a090
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HydroFrame 18 Advanced
• Version Model Number: 7118-1445-A1
• Catalog Number: 7118-1445
• 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
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• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812636024400 [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: 2018-11-21
• Device Publish Date: 2016-09-24

On-Brand Devices [HydroFrame 18 Advanced]

• 00812636024455: V-Trak
• 00812636024448: V-Trak
• 00812636024431: V-Trak
• 00812636024424: V-Trak
• 00812636024417: V-Trak
• 00812636024400: V-Trak
• 00812636024394: V-Trak
• 00812636024387: V-Trak
• 00812636024370: V-Trak
• 00812636024363: V-Trak
• 00812636024356: V-Trak
• 00812636024349: V-Trak
• 00812636024332: V-Trak
• 00812636024325: V-Trak
• 00811425029886: V-Trak
• 00811425029879: V-Trak
• 00811425029862: V-Trak
• 00811425029855: V-Trak
• 00811425029848: V-Trak
• 00811425029831: V-Trak
• 00811425029824: V-Trak
• 00811425029817: V-Trak
• 00811425029800: V-Trak
• 00811425029794: V-Trak
• 00811425029787: V-Trak
• 00811425029770: V-Trak
• 00811425029763: V-Trak
• 00811425029756: V-Trak
• 00811425029749: V-Trak