Duns Number:006999528
Device Description: Multi pack of 40 - 8 light/16 Regular/16 Super
Catalog Number
-
Brand Name
Kroger Tampons
Version/Model Number
BKGAC40
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
-
Product Code Name
-
Public Device Record Key
58d67c01-9e25-4143-b167-9f6f9c95fe21
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 20, 2016
Package DI Number
10041260335331
Quantity per Package
6
Contains DI Package
00011110353597
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 13 |
2 | A medical device with a moderate to high risk that requires special controls. | 15 |