miraDry
GUDID 00853419006008
Console
MIRAMAR LABS, 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 | 00853419006008 |
| NIH Device Record Key | cf3679de-9b12-47b2-a8c4-18256e181940 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | miraDry |
| Version Model Number | MD4000-MC |
| Company DUNS | 008226764 |
| Company Name | MIRAMAR LABS, 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 | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853419006008 [Primary] |
FDA Product Code
| MWY | System,Microwave,Hair Removal |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-30 |
On-Brand Devices [miraDry]
| 00853419006039 | bioTip |
| 00853419006022 | bioTip |
| 00853419006015 | Handpiece |
| 00853419006008 | Console |
Trademark Results [miraDry]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MIRADRY 85774022 4358051 Live/Registered |
MIRADRY, INC. 2012-11-07 |
 MIRADRY 85773803 4358050 Live/Registered |
MIRADRY, INC. 2012-11-07 |
 MIRADRY 77886437 3998953 Live/Registered |
MIRADRY, INC. 2009-12-04 |
 MIRADRY 77886273 3998952 Live/Registered |
MIRADRY, INC. 2009-12-04 |
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