Regatta® Plate RP2-004003

GUDID 10889981319922

Plate Inserter Wrench

SEASPINE ORTHOPEDICS CORPORATION

Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable

• Primary Device ID: 10889981319922
• NIH Device Record Key: 5ba653c0-6ab3-48e7-b1d0-4b4645672d5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Regatta® Plate
• Version Model Number: RP2-004003
• Catalog Number: RP2-004003
• 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	10889981319922 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200885

FDA Product Code

• KQW: Goniometer, nonpowered

Sterilization

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

[10889981319922]

Moist Heat or Steam Sterilization

[10889981319922]

Moist Heat or Steam Sterilization

[10889981319922]

Moist Heat or Steam Sterilization

[10889981319922]

Moist Heat or Steam Sterilization

[10889981319922]

Moist Heat or Steam Sterilization

[10889981319922]

Moist Heat or Steam Sterilization

[10889981319922]

Moist Heat or Steam Sterilization

[10889981319922]

Moist Heat or Steam Sterilization

[10889981319922]

Moist Heat or Steam Sterilization

[10889981319922]

Moist Heat or Steam Sterilization

[10889981319922]

Moist Heat or Steam Sterilization

[10889981319922]

Moist Heat or Steam Sterilization

[10889981319922]

Moist Heat or Steam Sterilization

[10889981319922]

Moist Heat or Steam Sterilization

[10889981319922]

Moist Heat or Steam Sterilization

[10889981319922]

Moist Heat or Steam Sterilization

[10889981319922]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-14
• Device Publish Date: 2024-03-06

On-Brand Devices [Regatta® Plate]

• 10889981319922: Plate Inserter Wrench
• 10889981319915: Lateral Plate Guide Rod
• 10889981319908: Offset Lateral Plate Inserter