Core Values Tampons - HARMON STORES, INC.

Duns Number:804085293

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More Product Details

Catalog Number

-

Brand Name

Core Values Tampons

Version/Model Number

BHAGS18

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

HEB

Product Code Name

Tampon, Menstrual, Unscented

Device Record Status

Public Device Record Key

94313860-a4a0-479c-a232-2bcbd4e1edfe

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

July 31, 2017

Additional Identifiers

Package DI Number

10834533000957

Quantity per Package

12

Contains DI Package

00834533000950

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"HARMON STORES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 29
2 A medical device with a moderate to high risk that requires special controls. 7