Graftgun Universal Graft Delivery System

GUDID 00858406007426

Graftgun Universal Graft Delivery System labeled with a different catalog for Integrity Implants to distribute.

SURGENTEC, LLC

Orthopaedic cement dispenser

• Primary Device ID: 00858406007426
• NIH Device Record Key: 093f55e9-58b8-4fbb-b3aa-3dca64b217d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Graftgun Universal Graft Delivery System
• Version Model Number: IG-U-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	00858406007426 [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: 2019-12-05
• Device Publish Date: 2019-11-27

On-Brand Devices [Graftgun Universal Graft Delivery System]

• 00858406007006: GG-U-1000
• 00858406007426: Graftgun Universal Graft Delivery System labeled with a different catalog for Integrity Implants