Duns Number:012578514
Device Description: unscented cardboard applicator super tampons
Catalog Number
-
Brand Name
Select Brand Tampons
Version/Model Number
SB22012F/1
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)
-
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
cfd52d9d-35eb-441d-907c-7ef9837db0c2
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
November 10, 2016
Package DI Number
10015127010006
Quantity per Package
12
Contains DI Package
00015127010009
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 |