Duns Number:178161212
Device Description: Organic Cotton Comfort Applicator Tampons, Regular (plant-based plastic applicator)
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
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
7f0c45cf-56c6-411e-9ea8-bcc2deed0453
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
April 17, 2017
Package DI Number
10732913451088
Quantity per Package
12
Contains DI Package
00732913451081
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |