Facet FF2-000002

GUDID 10889981213152

Drill, 5.0mm

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic implant driver

• Primary Device ID: 10889981213152
• NIH Device Record Key: 1b254d6c-94f8-43e1-8930-2a682d3b1b5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Facet
• Version Model Number: FF2-000002
• Catalog Number: FF2-000002
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981213152 [Primary]

FDA Product Code

• HTW: BIT, DRILL

Sterilization

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

[10889981213152]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-17
• Device Publish Date: 2020-04-09

On-Brand Devices [Facet]

• 10889981122485: Facet Screw 4.5MM x 58MM
• 10889981213183: Facet Prep Instrumentation Tray - Lid
• 10889981213176: Facet Prep Instrumentation Tray - Base, Cervical
• 10889981213169: Tamp, 5.0mm
• 10889981213152: Drill, 5.0mm
• 10889981213145: Inserter, Cervical