Seventh Generation - Organic Cotton Applicator Tampons, Regular - SEVENTH GENERATION, INC.

Duns Number:178161212

Device Description: Organic Cotton Applicator Tampons, Regular

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More Product Details

Catalog Number

45103

Brand Name

Seventh Generation

Version/Model Number

Regular, with applicator

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 2019

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

1ce5ccab-bdb9-4f55-b9be-b867b0da9a00

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 08, 2016

Additional Identifiers

Package DI Number

10732913451033

Quantity per Package

12

Contains DI Package

00732913451036

Package Discontinue Date

July 31, 2019

Package Status

Not in Commercial Distribution

Package Type

Case

"SEVENTH GENERATION, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1