Mariner MCT MC2-004052

GUDID 10889981170271

Slim Head Inserter, Long

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 10889981170271
• NIH Device Record Key: 480ce47c-4c9c-4466-8319-995f86010f93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mariner MCT
• Version Model Number: MC2-004052
• Catalog Number: MC2-004052
• 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
• 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	10889981170271 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173882

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

[10889981170271]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-20
• Device Publish Date: 2021-10-12

On-Brand Devices [Mariner MCT]

• 10889987169934: Constrained Rod, 100mm, Precontoured
• 10889987169897: Constrained Rod, 80mm, Precontoured
• 10889987169828: Constrained Rod, 45mm, Precontoured
• 10889987170695: Rod Holder
• 10889981195878: Mariner Midline Retractor Tray, level 1
• 10889981195861: Mariner Midline Retractor Tray - Base
• 10889981195854: Mariner Midline Implant Tray - level 2
• 10889981195847: Mariner Midline Implant Tray - level 1
• 10889981195830: Mariner Midline Implant Tray - Base
• 10889981195823: Mariner Midline Instrument Tray 2 - level 2
• 10889981195816: Mariner Midline Instrument Tray 2 - level 1
• 10889981195809: Mariner Midline Instrument Tray 2 - Base
• 10889981195793: Mariner Midline Instrument Tray 1 - level 2
• 10889981195786: Mariner Midline Instrument Tray 1 - level 1
• 10889981195779: Mariner Midline Tray 1 - Base
• 10889981189440: Shank Inserter, Self-retaining, Short
• 10889981189433: Shank Inserter, Self-retaining
• 10889981195908: Mariner Midline Constrained Rod Caddy
• 10889981195892: Mariner Midline Shank Caddy Lid
• 10889981195885: Mariner Midline Shank Caddy
• 10889981230517: Light Cable Adapter, ACMI
• 10889981170691: Rod Holder
• 10889981170301: Counter Torque, Slim
• 10889981170295: Compressor, Slim
• 10889981170288: Rod Measurement Wand
• 10889981170271: Slim Head Inserter, Long
• 10889981170264: Slim Head Inserter, Short
• 10889981170240: Face-cutting Reamer, T-Handle
• 10889981170233: Face-cutting Reamer, Tri-flat
• 10889981170226: Face-cutting Reamer, A/O
• 10889981170219: Face-cutting Reamer, 1/4"Quick-connect
• 10889981170202: 4.0mm Drill, Solid, Tri-Flat
• 10889981170196: 4.0mm Drill, Solid, A/O QC
• 10889981170189: 4.0mm Drill, Solid, 1/4" QC
• 10889981170172: 3.5mm Drill, Solid, Tri-Flat
• 10889981170165: 3.5mm Drill, Solid, A/O QC
• 10889981170158: 3.5mm Drill, Solid, 1/4" QC
• 10889981170141: 3.0mm Drill, Solid, Tri-Flat
• 10889981170134: 3.0mm Drill, Solid, A/O QC
• 10889981170127: 3.0mm Drill, Solid, 1/4" QC
• 10889981170110: Cortical Screw Shank Driver, Long
• 10889981170103: Cortical Screw Shank Driver, Short
• 10889981170097: Cortical Screw Shank Driver
• 10889981170080: 6.5mm Tap, Cortical, Cannulated
• 10889981170073: 6.0mm Tap, Cortical, Cannulated
• 10889981170066: 5.5mm Tap, Cortical, Cannulated
• 10889981170059: 5.0mm Tap, Cortical, Cannulated
• 10889981170042: 4.5mm Tap, Cortical, Cannulated
• 10889981170035: Adjustable Drill Guide
• 10889981170028: 6.5mm Tap, Cortical, Solid