FDA.reportPublic FDA data

Henso

Primary DI
06970343581600
Brand
Henso
Company
Henso Medical (Hangzhou) Co., Ltd.
Model
Acne Patch
Published
2023-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970343581600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970343581600069703435816006970343581600

GMDN Terms#

Term, Definition table
TermDefinition
Inflammatory skin/nerve/joint disorder dressingA substance (e.g., cream, gel, solution, ointment) intended to be topically applied to the skin primarily to treat inflammatory disorders of the skin, nerves, and/or joints caused by a variety of disorders/insults (e.g., chronic inflammatory skin disorders, radiotherapy induced irritation, varicose veins, nappy rash, neuropathy, arthritis) to help reduce inflammation/irritation and associated symptoms through a physical mechanism; it may also be intended for prophylactic use and is not intended for application to open wounds. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421316098
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970343581631HensoHydrocolloid Dressing2023-02-14
06970343581648HensoMicroscope Slides2023-02-14
06970343581655HensoCover glass2023-02-14
06970343581662HensoPH Test Strips2023-02-14

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