miraDry

GUDID 00853419006008

Console

MIRAMAR LABS, INC.

Electrosurgical system generator
Primary Device ID00853419006008
NIH Device Record Keycf3679de-9b12-47b2-a8c4-18256e181940
Commercial Distribution StatusIn Commercial Distribution
Brand NamemiraDry
Version Model NumberMD4000-MC
Company DUNS008226764
Company NameMIRAMAR LABS, 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

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Handling Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Handling Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Handling Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Handling Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Handling Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal
Handling Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 55 KiloPascal and 101 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100853419006008 [Primary]

FDA Product Code

MWYSystem,Microwave,Hair Removal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-30

On-Brand Devices [miraDry]

00853419006039bioTip
00853419006022bioTip
00853419006015Handpiece
00853419006008Console

Trademark Results [miraDry]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MIRADRY
MIRADRY
85774022 4358051 Live/Registered
MIRADRY, INC.
2012-11-07
MIRADRY
MIRADRY
85773803 4358050 Live/Registered
MIRADRY, INC.
2012-11-07
MIRADRY
MIRADRY
77886437 3998953 Live/Registered
MIRADRY, INC.
2009-12-04
MIRADRY
MIRADRY
77886273 3998952 Live/Registered
MIRADRY, INC.
2009-12-04

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