Mariner RDX MX3-100010

GUDID 10889981321994

Mariner RDX Tray Level 1

SEASPINE ORTHOPEDICS CORPORATION

Instrument tray, reusable

• Primary Device ID: 10889981321994
• NIH Device Record Key: 38bb82c7-975e-4bc8-be55-f1d72061c8a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mariner RDX
• Version Model Number: MX3-100010
• Catalog Number: MX3-100010
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981321994 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222110

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[10889981321994]

Moist Heat or Steam Sterilization

[10889981321994]

Moist Heat or Steam Sterilization

[10889981321994]

Moist Heat or Steam Sterilization

[10889981321994]

Moist Heat or Steam Sterilization

[10889981321994]

Moist Heat or Steam Sterilization

[10889981321994]

Moist Heat or Steam Sterilization

[10889981321994]

Moist Heat or Steam Sterilization

[10889981321994]

Moist Heat or Steam Sterilization

[10889981321994]

Moist Heat or Steam Sterilization

[10889981321994]

Moist Heat or Steam Sterilization

[10889981321994]

Moist Heat or Steam Sterilization

[10889981321994]

Moist Heat or Steam Sterilization

[10889981321994]

Moist Heat or Steam Sterilization

[10889981321994]

Moist Heat or Steam Sterilization

[10889981321994]

Moist Heat or Steam Sterilization

[10889981321994]

Moist Heat or Steam Sterilization

[10889981321994]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-13
• Device Publish Date: 2024-12-05

On-Brand Devices [Mariner RDX]

• 10889981289874: Mariner RDX Tab Remover
• 10889981289867: Mariner RDX Reamer
• 10889981289744: Mariner RDX Locking Cap
• 10889981289829: Mariner RDX Locking Cap Loader 2
• 10889981321994: Mariner RDX Tray Level 1
• 10889981321987: Mariner RDX Dual Tab Remover