FMX FMG1

GUDID 00859729006004

FMX G1 Generator

DOMAIN SURGICAL, INC.

Electrosurgical system generator

• Primary Device ID: 00859729006004
• NIH Device Record Key: c915f5f4-0f12-4dfe-9ef8-a1ddd10b102f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FMX
• Version Model Number: G1
• Catalog Number: FMG1
• Company DUNS: 963249342
• Company Name: DOMAIN SURGICAL, INC.
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859729006004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110439

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-08

On-Brand Devices [FMX]

• 00859729006035: FMX G1 Generator Foot Pedal
• 00859729006028: FMX Reusable Power Module
• 00859729006011: FMX Disposable Power Module
• 00859729006004: FMX G1 Generator