Catalog Number

7290112450067

Brand Name

Silk'n

Version/Model Number

Tightra NA

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

KXQ

Product Code Name

Vibrator For Therapeutic Use, Genital

Public Device Record Key

08e540a6-47f6-4fd4-94bb-a18429b8c836

Public Version Date

December 05, 2018

Public Version Number

1

DI Record Publish Date

November 04, 2018

Package DI Number

37290112450068

Quantity per Package

1

Contains DI Package

17290112450064

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box