Duns Number:012578514
Device Description: unscented cardboard applicator plus tampons
Catalog Number
-
Brand Name
Select Brand Tampons
Version/Model Number
SB30824F/2
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
71b5139a-9950-4d04-a7ea-d6def4a40aa2
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
November 10, 2016
Package DI Number
10015127013533
Quantity per Package
24
Contains DI Package
00015127013536
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 |