GraftGun Universal Graft Delivery System - Additional 5cc Graft Tube - IOSAL

GUDID 00810131881122

SURGENTEC, LLC

Syringe dose safety regulator

• Primary Device ID: 00810131881122
• NIH Device Record Key: 3302b18e-8554-4e3c-9ba5-e7c2914a8a18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GraftGun Universal Graft Delivery System - Additional 5cc Graft Tube - IOSAL
• Version Model Number: GG-T-01-IB
• 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: true
• 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	00810131881122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170675

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: 2025-02-20
• Device Publish Date: 2025-02-12

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