FMX

Basic Information

• Brand Name: FMX
• Primary DI: 00859729006004
• Version / Model: G1
• Catalog Number: FMG1
• Company Name: DOMAIN SURGICAL, INC.
• Labeler DUNS: 963249342
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-08
• Public Version: 4
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: c915f5f4-0f12-4dfe-9ef8-a1ddd10b102f

Device Description

FMX G1 Generator

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11490	Electrosurgical system generator	An electrically-powered component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for inert gas-enhanced electrosurgery.	No	Active
57825	Electrosurgical/ultrasonic surgical system generator	A mains electricity-powered (AC-powered) device designed to provide high frequency electrical current to power connected electrosurgical diathermy instruments (create heat within tissues) and ultrasonic surgical instruments (rapidly vibrate tissues), enabling a combination of methods to cut and/or coagulate tissues during open or laparoscopic surgery; the instruments are not included. The device may be used for various types of surgery (e.g., general, gynaecological, plastic); it is typically regulated by the operator with a hand- or foot-switch.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859729006004	GS1

Premarket Submissions

Submission Number	Supplement Number
K110439	000