Duns Number:128990418
Device Description: Amazon Basics Non Applicator tampons, Super Plus Absorbency, 32 count
Catalog Number
-
Brand Name
Amazon Basics
Version/Model Number
BANDP32
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
K965064,K965064,K965064
Product Code
HEB
Product Code Name
Tampon, Menstrual, Unscented
Public Device Record Key
6002153f-3263-4839-b695-0c2bcf4f9e5e
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
October 31, 2021
Package DI Number
10195515003411
Quantity per Package
12
Contains DI Package
00195515003414
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |