Duns Number:402746917
Device Description: This ice globe is made of 304 stainless steel and filled with refrigerant. Put it in the r 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.
Catalog Number
-
Brand Name
Stainless Steel Facial Ice Globe
Version/Model Number
Duo Set
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LYG
Product Code Name
Massager, Therapeutic, Manual
Public Device Record Key
df42ec78-f992-47a2-adc5-01e3d8c7420f
Public Version Date
October 31, 2022
Public Version Number
1
DI Record Publish Date
October 22, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |