FMX FMRPM

GUDID 00859729006028

FMX Reusable Power Module

DOMAIN SURGICAL, INC.

Electrosurgical handpiece, reusable
Primary Device ID00859729006028
NIH Device Record Key3cf70030-3ec2-4d79-be22-a23ac6fcc097
Commercial Distribution StatusIn Commercial Distribution
Brand NameFMX
Version Model NumberRPM
Catalog NumberFMRPM
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100859729006028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00859729006028]

Moist Heat or Steam Sterilization


[00859729006028]

Moist Heat or Steam Sterilization


[00859729006028]

Moist Heat or Steam Sterilization


[00859729006028]

Moist Heat or Steam Sterilization


[00859729006028]

Moist Heat or Steam Sterilization


[00859729006028]

Moist Heat or Steam Sterilization


[00859729006028]

Moist Heat or Steam Sterilization


[00859729006028]

Moist Heat or Steam Sterilization


[00859729006028]

Moist Heat or Steam Sterilization


[00859729006028]

Moist Heat or Steam Sterilization


[00859729006028]

Moist Heat or Steam Sterilization


[00859729006028]

Moist Heat or Steam Sterilization


[00859729006028]

Moist Heat or Steam Sterilization


[00859729006028]

Moist Heat or Steam Sterilization


[00859729006028]

Moist Heat or Steam Sterilization


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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