Graftgun Universal Graft Delivery System - Narrow Tip Adapter

GUDID 00858406007037

SURGENTEC, LLC

Orthopaedic cement dispenser

• Primary Device ID: 00858406007037
• NIH Device Record Key: 095c7e06-07cf-4235-bcd6-9bc15c2f2cd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Graftgun Universal Graft Delivery System - Narrow Tip Adapter
• Version Model Number: GG-NTA-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: 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	00858406007037 [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

[00858406007037]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-15
• Device Publish Date: 2019-01-24

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• 00810131880385 - TiLink-L Bone Graft Pusher Assembly: 2024-11-11
• 00810131880415 - Guidewire - 15.5": 2024-11-11