Graftgun® Universal (GDS™) Graft Delivery System- Additional 5cc Graftgun Tube

GUDID 00858406007136

SURGENTEC, LLC

Syringe dose safety regulator

• Primary Device ID: 00858406007136
• NIH Device Record Key: 5fef4677-09b6-4512-98c7-c40b8974318a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Graftgun® Universal (GDS™) Graft Delivery System- Additional 5cc Graftgun Tube
• Version Model Number: GG-T-01
• 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	00858406007136 [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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