Catalog Number

-

Brand Name

Natracare

Version/Model Number

Tampons Regular

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

K914430,K914430,K914430

Product Code

HEB

Product Code Name

Tampon, Menstrual, Unscented

Public Device Record Key

ff391e01-21bf-443d-8c8a-33de4bb55655

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

05019493081033

Quantity per Package

20

Contains DI Package

00782126181039

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton