Catalog Number

-

Brand Name

Kradsale Tampons

Version/Model Number

BKRGC36

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HEB

Product Code Name

Tampon, Menstrual, Unscented

Public Device Record Key

027411ee-49ea-4a54-a637-226cdba384d1

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

November 06, 2016

Package DI Number

10075130803583

Quantity per Package

6

Contains DI Package

00075130803586

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE