Mariner Cap 569326

GUDID 10889981220945

Mariner Cap SP Crimper

SEASPINE ORTHOPEDICS CORPORATION

Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner

• Primary Device ID: 10889981220945
• NIH Device Record Key: 8749bd15-745c-406f-a00a-31904beb3adc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mariner Cap
• Version Model Number: 569326
• Catalog Number: 569326
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981220945 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201240

FDA Product Code

• OWI: Bone fixation cerclage, sublaminar

Sterilization

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

[10889981220945]

Moist Heat or Steam Sterilization

[10889981220945]

Moist Heat or Steam Sterilization

[10889981220945]

Moist Heat or Steam Sterilization

[10889981220945]

Moist Heat or Steam Sterilization

[10889981220945]

Moist Heat or Steam Sterilization

[10889981220945]

Moist Heat or Steam Sterilization

[10889981220945]

Moist Heat or Steam Sterilization

[10889981220945]

Moist Heat or Steam Sterilization

[10889981220945]

Moist Heat or Steam Sterilization

[10889981220945]

Moist Heat or Steam Sterilization

[10889981220945]

Moist Heat or Steam Sterilization

[10889981220945]

Moist Heat or Steam Sterilization

[10889981220945]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-02
• Device Publish Date: 2020-11-24

On-Brand Devices [Mariner Cap]

• 10889981220945: Mariner Cap SP Crimper
• 10889981220938: Mariner Cap SP Tensioner
• 10889981220921: Mariner Cap SP Anti-torque wrench
• 10889981220914: Mariner CAP SP Tensionser Stem
• 10889981220907: Mariner Cap SP