FDA.reportPublic FDA data

miraDry

Primary DI
00853419006022
Brand
miraDry
Company
MIRADRY, INC.
Model
MD4000-BT
Catalog number
na
Device description
bioTip
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
00853419006022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853419006022008534190060228534190060220853419006022

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118454926
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853419006039miraDryMD4500-BTna2018-09-13
00853419006008miraDryMD4000-MC2016-09-30
00853419006015miraDryMD4000-HPna2016-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06954414601015Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
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06954414601039Microwave Ablation AntennasCanyon Medical Inc.NEY2025-03-14
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