Catalog Number

-

Brand Name

Sparkle

Version/Model Number

Applicator Super Plus

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

a6a2f6f2-2c2f-405b-a589-22f9606bf00c

Public Version Date

July 13, 2022

Public Version Number

1

DI Record Publish Date

July 05, 2022

Package DI Number

10850036179044

Quantity per Package

12

Contains DI Package

00850036179047

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case