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

Duns Number:178161212

Device Description: Organic Cotton Comfort Applicator Tampons, Regular (plant-based plastic applicator)

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More Product Details

Catalog Number

45108

Brand Name

Seventh Generation

Version/Model Number

Regular, with plant-based plastic applicator

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

7f0c45cf-56c6-411e-9ea8-bcc2deed0453

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

April 17, 2017

Additional Identifiers

Package DI Number

10732913451088

Quantity per Package

12

Contains DI Package

00732913451081

Package Discontinue Date

-

Package Status

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