Catalog Number

-

Brand Name

Viv

Version/Model Number

Organic Cotton Tampons with Bio-Applicator, Super

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K162746,K162746

Product Code

HEB

Product Code Name

Tampon, Menstrual, Unscented

Public Device Record Key

f6906da2-4e2e-4dda-908d-3ffc158aa2a6

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

April 26, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-