HydroSoft Helical 100506H2HS-V

GUDID 00811425026595

V-Trak

MICROVENTION INC.

Neurovascular embolization coil

• Primary Device ID: 00811425026595
• NIH Device Record Key: dfdbd6ce-fe45-4ae2-9670-1e38615489cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HydroSoft Helical
• Version Model Number: 100506H2HS-V-A
• Catalog Number: 100506H2HS-V
• 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
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811425026595 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091641

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

On-Brand Devices [HydroSoft Helical]

• 00811425022887: V-Trak
• 00811425021415: V-Trak
• 00811425020210: V-Trak
• 00811425020203: V-Trak
• 00811425020197: V-Trak
• 00811425020180: V-Trak
• 00811425020142: V-Trak
• 00811425020128: V-Trak
• 00810170019968: V-Trak
• 00810170019944: V-Trak
• 00810170019593: V-Trak
• 00810170019586: V-Trak
• 00810170019579: V-Trak
• 00810170019562: V-Trak
• 00810170019555: V-Trak
• 00810170019227: V-Trak
• 00810170019203: V-Trak
• 00810170016486: V-Trak
• 00810170016080: V-Trak
• 00810170016073: V-Trak
• 00810170016042: V-Trak
• 00810170016035: V-Trak
• 00810170016011: V-Trak
• 00810170016004: V-Trak
• 00810170015991: V-Trak
• 00810170015984: V-Trak
• 00810170015977: V-Trak
• 00810170015960: V-Trak
• 00810170015953: V-Trak
• 00810170015946: V-Trak
• 00810170015939: V-Trak
• 00810170015922: V-Trak
• 00810170015915: V-Trak
• 00810170015908: V-Trak
• 00810170015892: V-Trak
• 00810170015885: V-Trak
• 00810170015878: V-Trak
• 00810170014840: V-Trak
• 00810170014833: V-Trak
• 00810170014826: V-Trak
• 00810170014819: V-Trak
• 00810170014802: V-Trak
• 00810170014796: V-Trak
• 00810170014789: V-Trak
• 00810170014772: V-Trak
• 00810170014765: V-Trak
• 00810170014758: V-Trak
• 00810170014734: V-Trak
• 00810170014727: V-Trak
• 00810170014703: V-Trak