Virage® OCT 300P0003

GUDID 03662663080057

Open-Closed Connector (Ø3.5mm/4.0mm - Ø3.5mm/4.0mm)

Highridge Medical, LLC

Bone-screw internal spinal fixation system connector

• Primary Device ID: 03662663080057
• NIH Device Record Key: db80a375-5572-4fee-9869-1ae6ed23d7f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Virage® OCT
• Version Model Number: 300P0003
• Catalog Number: 300P0003
• Company DUNS: 119260394
• Company Name: Highridge Medical, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03662663080057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250332

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[03662663080057]

Moist Heat or Steam Sterilization

[03662663080057]

Moist Heat or Steam Sterilization

[03662663080057]

Moist Heat or Steam Sterilization

[03662663080057]

Moist Heat or Steam Sterilization

[03662663080057]

Moist Heat or Steam Sterilization

[03662663080057]

Moist Heat or Steam Sterilization

[03662663080057]

Moist Heat or Steam Sterilization

[03662663080057]

Moist Heat or Steam Sterilization

[03662663080057]

Moist Heat or Steam Sterilization

[03662663080057]

Moist Heat or Steam Sterilization

[03662663080057]

Moist Heat or Steam Sterilization

[03662663080057]

Moist Heat or Steam Sterilization

[03662663080057]

Moist Heat or Steam Sterilization

[03662663080057]

Moist Heat or Steam Sterilization

[03662663080057]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-02
• Device Publish Date: 2025-04-24

On-Brand Devices [Virage® OCT]

• 03662663079877: Head-to-Rod Connector Lock Nut
• 03662663079860: Head-to-Rod Connector Tall Closure Top
• 03662663079853: Head-to-Rod Channel Connector (Ø3.5mm/4.0mm - Ø3.5mm/4.0mm)
• 03662663080101: Open-Channel Connector (Ø3.5mm/4.0mm - Ø5.5mm/6.0mm)
• 03662663080064: Open-Closed Connector (Ø3.5mm/4.0mm - Ø5.5mm/6.0mm)
• 03662663080057: Open-Closed Connector (Ø3.5mm/4.0mm - Ø3.5mm/4.0mm)
• 03662663079846: Open-Channel Connector (Ø3.5mm/4.0mm - Ø3.5mm/4.0mm)
• 03662663079839: Axial 2 Screw Connector (Ø3.5mm/4.0mm - Ø5.5mm/6.0mm)
• 03662663079822: Axial 2 Screw Connector (Ø3.5mm/4.0mm - Ø3.5mm/4.0mm)
• 03662663079815: Open-Open Connector (Ø3.5mm/4.0mm - Ø5.5mm/6.0mm)
• 03662663079808: Open-Open Connector (Ø3.5mm/4.0mm - Ø3.5mm/4.0mm)