miraDry na
GUDID 00853419006015
Handpiece
MIRAMAR LABS, INC.
Electrosurgical system generator| Primary Device ID | 00853419006015 |
| NIH Device Record Key | 02fe1a35-51a9-4f95-9947-678ef4512196 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | miraDry |
| Version Model Number | MD4000-HP |
| Catalog Number | na |
| 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 | 00853419006015 [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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