Lateral SI Screw Inserter Torque Driver

GUDID 00850040139921

SURGENTEC, LLC

Orthopaedic fixation plate, bioabsorbable

• Primary Device ID: 00850040139921
• NIH Device Record Key: 4a2ab9f1-c1c2-4dab-afee-fd45fdfd29f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lateral SI Screw Inserter Torque Driver
• Version Model Number: SR21-6004
• Company DUNS: 004095409
• Company Name: SURGENTEC, LLC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00850040139921 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230446

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[00850040139921]

Moist Heat or Steam Sterilization

[00850040139921]

Moist Heat or Steam Sterilization

[00850040139921]

Moist Heat or Steam Sterilization

[00850040139921]

Moist Heat or Steam Sterilization

[00850040139921]

Moist Heat or Steam Sterilization

[00850040139921]

Moist Heat or Steam Sterilization

[00850040139921]

Moist Heat or Steam Sterilization

[00850040139921]

Moist Heat or Steam Sterilization

[00850040139921]

Moist Heat or Steam Sterilization

[00850040139921]

Moist Heat or Steam Sterilization

[00850040139921]

Moist Heat or Steam Sterilization

[00850040139921]

Moist Heat or Steam Sterilization

[00850040139921]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-11
• Device Publish Date: 2024-11-01

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• 00810131880071 - TiLink-L Transfer Pin: 2024-11-11
• 00810131880248 - TiLink-L Implant Caddy: 2024-11-11
• 00810131880255 - TiLink-L Sterilization Tray: 2024-11-11
• 00810131880316 - TiLink-L Reamer: 2024-11-11
• 00810131880378 - TiLink-L Bone Graft Funnel: 2024-11-11
• 00810131880385 - TiLink-L Bone Graft Pusher Assembly: 2024-11-11
• 00810131880415 - Guidewire - 15.5": 2024-11-11