Catalog Number

-

Brand Name

Cora

Version/Model Number

02Tampons-118

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

2b8212ad-35ee-4ccc-b661-3d83f05086b3

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

December 03, 2019

Package DI Number

10850373007970

Quantity per Package

24

Contains DI Package

00850373007973

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case