Mariner RDX MIS MX1-001010

GUDID 10889981298647

Mariner RDX MIS Polyaxial Head

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10889981298647
• NIH Device Record Key: 269743b6-73e2-4751-9bda-accd41c7f0de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mariner RDX MIS
• Version Model Number: MX1-001010
• Catalog Number: MX1-001010
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981298647 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222110

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[10889981298647]

Moist Heat or Steam Sterilization

[10889981298647]

Moist Heat or Steam Sterilization

[10889981298647]

Moist Heat or Steam Sterilization

[10889981298647]

Moist Heat or Steam Sterilization

[10889981298647]

Moist Heat or Steam Sterilization

[10889981298647]

Moist Heat or Steam Sterilization

[10889981298647]

Moist Heat or Steam Sterilization

[10889981298647]

Moist Heat or Steam Sterilization

[10889981298647]

Moist Heat or Steam Sterilization

[10889981298647]

Moist Heat or Steam Sterilization

[10889981298647]

Moist Heat or Steam Sterilization

[10889981298647]

Moist Heat or Steam Sterilization

[10889981298647]

Moist Heat or Steam Sterilization

[10889981298647]

Moist Heat or Steam Sterilization

[10889981298647]

Moist Heat or Steam Sterilization

[10889981298647]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-03
• Device Publish Date: 2023-03-24

On-Brand Devices [Mariner RDX MIS]

• 10889981300043: Mariner RDX MIS Stylet
• 10889981300036: Mariner RDX MIS Counter Torque Handle
• 10889981298654: Mariner RDX MIS Counter Torque
• 10889981298647: Mariner RDX MIS Polyaxial Head