FMX FMG1

GUDID 00859729006004

FMX G1 Generator

DOMAIN SURGICAL, INC.

Electrosurgical system generator
Primary Device ID00859729006004
NIH Device Record Keyc915f5f4-0f12-4dfe-9ef8-a1ddd10b102f
Commercial Distribution StatusIn Commercial Distribution
Brand NameFMX
Version Model NumberG1
Catalog NumberFMG1
Company DUNS963249342
Company NameDOMAIN SURGICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100859729006004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-08

On-Brand Devices [FMX]

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

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