Catalog Number

-

Brand Name

Every Cycle

Version/Model Number

7000

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K211519

Product Code

HEB

Product Code Name

Tampon, Menstrual, Unscented

Public Device Record Key

b40fc9c7-a3b6-454f-89c4-74d8812ef596

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 10, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-