Mariner MIS TLIF Retractor MR2-003102

GUDID 10889981277857

Medial Blade Extension Lg, Lateral Rack, Right

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver

• Primary Device ID: 10889981277857
• NIH Device Record Key: a2c9becc-b2b9-46e8-9cec-ad2ce15b038c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mariner MIS TLIF Retractor
• Version Model Number: MR2-003102
• Catalog Number: MR2-003102
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981277857 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183639

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[10889981277857]

Moist Heat or Steam Sterilization

[10889981277857]

Moist Heat or Steam Sterilization

[10889981277857]

Moist Heat or Steam Sterilization

[10889981277857]

Moist Heat or Steam Sterilization

[10889981277857]

Moist Heat or Steam Sterilization

[10889981277857]

Moist Heat or Steam Sterilization

[10889981277857]

Moist Heat or Steam Sterilization

[10889981277857]

Moist Heat or Steam Sterilization

[10889981277857]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-25
• Device Publish Date: 2021-08-17

On-Brand Devices [Mariner MIS TLIF Retractor]

• 10889981230616: Shank/Blade Driver, Long
• 10889981230609: Shank/Blade Driver, Short
• 10889981230579: Retractor Base Wrench, Quick-connect
• 10889981230487: MIS Retractor, Tray Level 1
• 10889981230470: MIS Retractor Tray Case
• 10889981218621: Table Arm
• 10889981218591: Shank/Blade Driver
• 10889981277857: Medial Blade Extension Lg, Lateral Rack, Right
• 10889981277840: Medial Blade Extension Lg, Lateral Rack, Left
• 10889981206192: Retractor Base Wrench