Duns Number:178161212
Device Description: Organic Cotton Applicator Tampons, Regular
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
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
1ce5ccab-bdb9-4f55-b9be-b867b0da9a00
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 08, 2016
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
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |