FDA.reportPublic FDA data

Stainless Steel Facial Ice Globe

Primary DI
00860009308008
Brand
Stainless Steel Facial Ice Globe
Company
Jiangmen Shengke Hardware Products Co., Ltd
Model
Set
Device description
This ice globe is made of 304 stainless steel and filled with refrigerant. Put it in the refrigerator for 3-4 hours before use, roll it slowly on the face, and enjoy the cool and calm massage effect. It is applicable to the face, neck and other parts.
Published
2022-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00860009308008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009308008008600093080088600093080080860009308008

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
402746917
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009308015Stainless Steel Facial Ice GlobeDuo Set2022-10-22

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