Graftgun Universal Graft Delivery System -Long Narrow Tip Adapter

GUDID 00858406007099

SURGENTEC, LLC

Orthopaedic cement dispenser

• Primary Device ID: 00858406007099
• NIH Device Record Key: fef0c289-8f20-41f0-a8cf-a465019957ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Graftgun Universal Graft Delivery System -Long Narrow Tip Adapter
• Version Model Number: GG-NTA-02
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858406007099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170675

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

[00858406007099]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-22
• Device Publish Date: 2019-04-13

Devices Manufactured by SURGENTEC, LLC

• 00858406007259 - 6mm Dilator: 2024-12-26
• 00858406007266 - 10mm Dilator: 2024-12-26
• 00858406007273 - 17mm Dilator: 2024-12-26
• 00858406007280 - 20mm Dilator: 2024-12-26
• 00858406007532 - 13mm Dilator: 2024-12-26
• 00858406007631 - GraftRasp Sterilization Tray: 2024-12-26
• 00858406007716 - 3/4 inch Cobb: 2024-12-26
• 00810131880910 - Guide Pin - Bevel: 2024-12-17