Regatta Lateral System 36-99-5000-13

GUDID 10889981162764

Regatta Instrument Tray Non-Lordotic Trial Caddy

SEASPINE ORTHOPEDICS CORPORATION

Instrument tray

• Primary Device ID: 10889981162764
• NIH Device Record Key: 6276dc11-b9ea-4b68-bd47-c0184cd724cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Regatta Lateral System
• Version Model Number: 36-99-5000-13
• Catalog Number: 36-99-5000-13
• Company DUNS: 079840876
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
• 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	10889981162764 [Primary]

FDA Product Code

• OJH: Orthopedic tray

Sterilization

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

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

[10889981162764]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-16
• Device Publish Date: 2018-09-15

On-Brand Devices [Regatta Lateral System]

• 10889987164793: Lateral Disc Prep Instrument Tray Case
• 10889987164786: Lateral Disc Prep Instrument Tray Level Bottom
• 10889987164779: Lateral Disc Prep Instrument Tray Level Top
• 10889987164762: Angled Lateral Disc Prep Instrument Tray Case
• 10889987164755: Angled Lateral Disc Prep Instrument Tray Bottom
• 10889987164748: Angled Lateral Disc Prep Instrument Tray Top
• 10889987163123: Lateral Box Cutter, 6x23mm
• 10889986163117: Lateral Box Cutter, 4x23mm
• 10889981170783: Osteophyte Biter
• 10889981170776: Down Biting Curette, Small
• 10889981163044: Trial, 23mm x 16mm x 55mm, 15 Deg
• 10889981163037: Trial, 23mm x 16mm x 55mm, 10 Deg
• 10889981163013: Trial, 23mm x 14mm x 55mm, 15 Deg
• 10889981163006: Trial, 23mm x 14mm x 55mm, 10 Deg
• 10889981162993: Trial, 23mm x 14mm x 55mm, 0 Deg
• 10889981162986: Trial, 23mm x 12mm x 55mm, 15 Deg
• 10889981162979: Trial, 23mm x 12mm x 55mm, 10 Deg
• 10889981162962: Trial, 23mm x 12mm x 55mm, 0 Deg
• 10889981162955: Trial, 23mm x 10mm x 55mm, 15 Deg
• 10889981162948: Trial, 23mm x 10mm x 55mm, 10 Deg
• 10889981162931: Trial, 23mm x 10mm x 55mm, 0 Deg
• 10889981162924: Trial, 23mm x 8mm x 55mm, 10 Deg
• 10889981162917: Trial, 23mm x 8mm x 55mm, 0 Deg
• 10889981162900: Trial, 18mm x 16mm x 55mm, 15 Deg
• 10889981162894: Trial, 18mm x 16mm x 55mm, 10 Deg
• 10889981162870: Trial, 18mm x 14mm x 55mm, 15 Deg
• 10889981162863: Trial, 18mm x 14mm x 55mm, 10 Deg
• 10889981162856: Trial, 18mm x 14mm x 55mm, 0 Deg
• 10889981162849: Trial, 18mm x 12mm x 55mm, 15 Deg
• 10889981162832: Trial, 18mm x 12mm x 55mm, 10 Deg
• 10889981162825: Trial, 18mm x 12mm x 55mm, 0 Deg
• 10889981162818: Trial, 18mm x 10mm x 55mm, 15 Deg
• 10889981162801: Trial, 18mm x 10mm x 55mm, 10 Deg
• 10889981162795: Trial, 18mm x 10mm x 55mm, 0 Deg
• 10889981162788: Trial, 18mm x 8mm x 55mm, 10 Deg
• 10889981162771: Trial, 18mm x 8mm x 55mm, 0 Deg
• 10889981162764: Regatta Instrument Tray Non-Lordotic Trial Caddy
• 10889981162757: Regatta Instrument Tray Wide Trial Caddy
• 10889981162740: Regatta Instrument Tray Narrow Trial Caddy
• 10889981162733: Regatta Instrument Tray Case
• 10889981162726: Regatta Instrument Tray Level Bottom
• 10889981162719: Regatta Instrument Tray Level Top
• 10889981162702: Regatta Instrument Tray
• 10889981162665: Lateral Paddle Shaver, 6mm
• 10889981162658: Lateral Paddle Shaver, 4mm
• 10889981162641: Lateral Box Cutter, 6x23mm, Angled
• 10889981162634: Lateral Box Cutter, 4x23mm, Angled
• 10889981162627: Lateral Box Cutter, 4x18mm, Angled
• 10889981162610: Lateral Box Cutter, 6x18mm
• 10889981162603: Lateral Box Cutter, 4x18mm, Angled