FRF AG602426A

GUDID 17290016633150

Fractora 24P

INMODE M.D LTD

Radio-frequency skin surface treatment system
Primary Device ID17290016633150
NIH Device Record Keyde2cf843-800f-436a-9f80-786ebb0a6f72
Commercial Distribution StatusIn Commercial Distribution
Brand NameFRF
Version Model NumberAG602426A
Catalog NumberAG602426A
Company DUNS600417351
Company NameINMODE M.D LTD
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-887-367-4556
Emailcontact@inmode.com
Phone1-887-367-4556
Emailcontact@inmode.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 90 KiloPascal and 110 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016633153 [Unit of Use]
GS117290016633150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[17290016633150]

Dry Heat Sterilization


[17290016633150]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-25

On-Brand Devices [FRF]

17290016633167Fractora 24P
17290016633150Fractora 24P

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