FDA.reportPublic FDA data

ARTSUN

Primary DI
06976012450147
Brand
ARTSUN
Company
Dongguan Dengrong Arts & Crafts Co., Ltd.
Model
ROSE QUARTZ MINI ROSE GOLD ROLL GUASHA SET
Published
2023-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LYGMassager, Therapeutic, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYGMassager, Therapeutic, ManualPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976012450147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976012450147069760124501476976012450147

GMDN Terms#

Term, Definition table
TermDefinition
External manual massager, home-useA manual (non-powered) device specifically designed to apply external massage in the home. It is typically held in the hand of the user and drawn/rolled across the area of the body/muscles to be treated; it may also be designed to be placed on the floor for foot massage. The massaging components, e.g., roller heads or pads, may be interchangeable with others of different size and shape. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
403699255
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976012450222ARTSUNOPAL GUA SHA SET2024-11-27
06976012450239ARTSUNCLEAR QUARTZ SILVER ROLLER GUA SHA SET2024-11-27
06976012450178ARTSUNCLEAR QUARTZ FLORAL ROLLER2023-05-02
06976012450185ARTSUNCOLOURED TOURQISE RAINBOW STONE GUA SHA (RED)2023-05-02
06976012450192ARTSUNPINK RG CRYSTAL HANDLE ROLLER2023-05-02
06976012450208ARTSUNOPAL TRAVEL SET2023-05-02
06976012450086ARTSUNPINK ROSE GOLD ROLLER2023-02-21
06976012450093ARTSUNGREEN GOLD ROLLER2023-02-21
06976012450109ARTSUNPINK GOLD CRYSTAL HANDLE2023-02-21
06976012450116ARTSUNJADE CRYSTAL GOLD ROLLER2023-02-21
06976012450123ARTSUNJADE FLORAL ROSE GOLD ROLLER2023-02-21
06976012450130ARTSUNROSE QUARTZ CRYSTAL ROLLER GUA SHA SET 2023-02-21
06976012450154ARTSUNJADE GUASHA SET2023-02-21
06976012450161ARTSUNROSE QUARTZ STD HEART GUA SHA2023-02-21
06976012450000ARTSUNJADE BODY GUA SHA2023-01-13
06976012450017ARTSUNV SHAPE ROSE QUARTZ GOLDEN ROLLER2023-01-13
06976012450024ARTSUNROSE QUARTZ MASSAGE WAND &GUA SHA SET2023-01-13
06976012450031ARTSUNROSE QUARTZ FLORAL ROSE GOLD ROLLER2023-01-13
06976012450048ARTSUNJADE CRYSTAL GOLD ROLLER GUA SHA SET2023-01-13
06976012450055ARTSUNROSE QUARTZ HEART SHAPE GUA SHA2023-01-13

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Primary DI, Brand, Company table
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