Universal Graftgun Kit

GUDID 00810131881290

SURGENTEC, LLC

Orthopaedic cement ultrasonic surgical system handpiece tip, reusable

• Primary Device ID: 00810131881290
• NIH Device Record Key: a1cd43e2-64c3-444c-ba2c-cc02ab47c54e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal Graftgun Kit
• Version Model Number: RED-U-1000
• 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: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810131881290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243580

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-18
• Device Publish Date: 2025-06-10

Devices Manufactured by SURGENTEC, LLC

• 00810131880439 - TiLink-L Implant 30mm x 10mm: 2025-06-18
• 00810131880446 - TiLink-L Implant 35mm x 10mm: 2025-06-18
• 00810131880453 - TiLink-L Implant 40mm x 10mm: 2025-06-18
• 00810131880460 - TiLink-L Implant 45mm x 10mm: 2025-06-18
• 00810131880477 - TiLink-L Implant 50mm x 10mm: 2025-06-18
• 00810131880484 - TiLink-L Implant 55mm x 10mm: 2025-06-18
• 00810131880491 - TiLink-L Implant 60mm x 10mm: 2025-06-18
• 00810131880613 - TiLink-P Screw 12mm x 30mm: 2025-06-18