Graftgun Universal Graft Delivery System - Cartridge Kit

GUDID 00858406007044

SURGENTEC, LLC

Orthopaedic cement dispenser

• Primary Device ID: 00858406007044
• NIH Device Record Key: a4809323-ade3-46ab-877d-dd60f80a941a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Graftgun Universal Graft Delivery System - Cartridge Kit
• Version Model Number: GG-K-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: 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	00858406007044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180937

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: 2018-09-10
• Device Publish Date: 2018-08-09

On-Brand Devices [Graftgun Universal Graft Delivery System - Cartridge Kit]

• 00858406007044: GG-K-1000
• 00858406007433: Graftgun Universal Graft Delivery System - Cartridge Kit labeled with new catalog number for dis