Duns Number:514891048
Device Description: 1 Brick without accessories
Catalog Number
7290016627688
Brand Name
Silk'n
Version/Model Number
Lipo (1 Brick)
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
ISA
Product Code Name
Massager, Therapeutic, Electric
Public Device Record Key
b8caa3a3-c4db-4cd3-a7dd-6817ada0f5ff
Public Version Date
February 19, 2021
Public Version Number
5
DI Record Publish Date
June 11, 2018
Package DI Number
37290016627689
Quantity per Package
4
Contains DI Package
17290016627685
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box of 4
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 14 |