Ventura NanoMetalene Sterile 93-3805

GUDID 10889981170349

Ventura NanoMetalene Straight Inserter

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 10889981170349
• NIH Device Record Key: e30e5118-d80c-416e-aed6-984fcc57724f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ventura NanoMetalene Sterile
• Version Model Number: 93-3805
• Catalog Number: 93-3805
• Company DUNS: 079840876
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981170349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142488

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[10889981170349]

Moist Heat or Steam Sterilization

[10889981170349]

Moist Heat or Steam Sterilization

[10889981170349]

Moist Heat or Steam Sterilization

[10889981170349]

Moist Heat or Steam Sterilization

[10889981170349]

Moist Heat or Steam Sterilization

[10889981170349]

Moist Heat or Steam Sterilization

[10889981170349]

Moist Heat or Steam Sterilization

[10889981170349]

Moist Heat or Steam Sterilization

[10889981170349]

Moist Heat or Steam Sterilization

[10889981170349]

Moist Heat or Steam Sterilization

[10889981170349]

Moist Heat or Steam Sterilization

[10889981170349]

Moist Heat or Steam Sterilization

[10889981170349]

Moist Heat or Steam Sterilization

[10889981170349]

Moist Heat or Steam Sterilization

[10889981170349]

Moist Heat or Steam Sterilization

[10889981170349]

Moist Heat or Steam Sterilization

[10889981170349]

Moist Heat or Steam Sterilization

[10889981170349]

Moist Heat or Steam Sterilization

[10889981170349]

Moist Heat or Steam Sterilization

[10889981170349]

Moist Heat or Steam Sterilization

[10889981170349]

Moist Heat or Steam Sterilization

[10889981170349]

Moist Heat or Steam Sterilization

[10889981170349]

Moist Heat or Steam Sterilization

[10889981170349]

Moist Heat or Steam Sterilization

[10889981170349]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-08
• Device Publish Date: 2021-09-30

On-Brand Devices [Ventura NanoMetalene Sterile]

• 10889981170387: Graft Tamp
• 10889981170370: Angled Pusher
• 10889981170363: Straight Pusher
• 10889981170356: Ventura NanoMetalene Offset MIS Inserter
• 10889981170349: Ventura NanoMetalene Straight Inserter