FDA.reportPublic FDA data

miraDry

Primary DI
00853419006015
Brand
miraDry
Company
MIRADRY, INC.
Model
MD4000-HP
Catalog number
na
Device description
Handpiece
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MWYSystem,Microwave,Hair Removal
NEYSystem, Ablation, Microwave And Accessories
OUBInstrument For Treatment Of Hyperhidrosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWYSystem, Microwave, Hair RemovalGeneral, Plastic Surgery2
NEYSystem, Ablation, Microwave And AccessoriesGeneral, Plastic Surgery2
OUBInstrument For Treatment Of HyperhidrosisGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853419006015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853419006015008534190060158534190060150853419006015

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical system generatorA mains electricity-powered (AC-powered) component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure55 KiloPascal101 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-29 Degrees Celsius60 Degrees Celsius
Storage Environment Atmospheric Pressure55 KiloPascal101 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-29 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118454926
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853419006039miraDryMD4500-BTna2018-09-13
00853419006008miraDryMD4000-MC2016-09-30
00853419006022miraDryMD4000-BTna2016-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935650621319HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650621333HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650621357HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650621371HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622613HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622620HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622637HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622651HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622668HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622682HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622699HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650622729HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650623344HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650623351HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650624327HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650626048HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650626451HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
06935650626468HYGEAHygea Medical Technology Co., Ltd.NEY2025-09-08
05060359560971MicroBlate FineCREO MEDICAL LIMITEDNEY2025-05-05
05060359560490MicroBlate FineCREO MEDICAL LIMITEDNEY2025-05-05
06954414601015Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601022Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601039Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601046Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601053Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601060Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601077Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601084Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601107Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
06954414601121Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14