Catalog Number

-

Brand Name

Naturelle

Version/Model Number

251765

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K031067,K031067,K031067,K031067,K031067

Product Code

HEB

Product Code Name

Tampon, Menstrual, Unscented

Public Device Record Key

a5ecbb8b-a216-4374-bf32-cbf653fc6ebe

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

January 26, 2017

Package DI Number

B34025160273

Quantity per Package

50

Contains DI Package

B3402517650

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Convenience Pack