FMX FMG1

GUDID 00859729006004

FMX G1 Generator

DOMAIN SURGICAL, INC.

Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator 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