Avenue

GUDID H96590632449010

Avenue Insertion Tool

NAVILYST MEDICAL, INC.

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• Primary Device ID: H96590632449010
• NIH Device Record Key: adff39c4-8403-45f0-8bc5-8afba2dd46e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avenue
• Version Model Number: 9063244901
• Company DUNS: 809699023
• Company Name: NAVILYST MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• 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(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H96590632449010 [Primary]
HIBCC	H96590632449011 [Package]; Package: BOX [1000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922410

FDA Product Code

• DQX: WIRE, GUIDE, CATHETER

Sterilization

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

[H96590632449010]

Ethylene Oxide

[H96590632449010]

Ethylene Oxide

[H96590632449010]

Ethylene Oxide

[H96590632449010]

Ethylene Oxide

[H96590632449010]

Ethylene Oxide

[H96590632449010]

Ethylene Oxide

[H96590632449010]

Ethylene Oxide

[H96590632449010]

Ethylene Oxide

[H96590632449010]

Ethylene Oxide

[H96590632449010]

Ethylene Oxide

[H96590632449010]

Ethylene Oxide

[H96590632449010]

Ethylene Oxide

[H96590632449010]

Ethylene Oxide

[H96590632449010]

Ethylene Oxide

[H96590632449010]

Ethylene Oxide

[H96590632449010]

Ethylene Oxide

[H96590632449010]

Ethylene Oxide

[H96590632449010]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2016-09-21

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