Catalog Number

7290016627664

Brand Name

Silk'n

Version/Model Number

Lipo Duo

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

80c6a25d-4624-4353-8a1d-fdb835786fd1

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

May 27, 2018

Package DI Number

37290016627665

Quantity per Package

4

Contains DI Package

17290016627661

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box of 4