Catalog Number

-

Brand Name

Safe & Soft tampons

Version/Model Number

BKDRBK500

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

K965064,K965064

Product Code

HEB

Product Code Name

Tampon, Menstrual, Unscented

Public Device Record Key

7fddda31-0126-4f6e-bd09-3bff59eaa081

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

December 04, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-