Duns Number:062312574
Device Description: The device will be offered as a traditional unscented menstrual 100% cotton tampon consist The device will be offered as a traditional unscented menstrual 100% cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator.The box contains two types of tampons (18+18) offered in two absorbencies: Regular and Super.Each tampon is individually wrapped with two different color and packaged in multi -unit containers for retail sale. Regular (green wrapper) and Super (pink wrapper).Each tampon is registered in GUDID database with a different Primary DI Number:- Applicator Regular : 00050428516706- Applicator Super : 00050428513279
Catalog Number
-
Brand Name
CVS Pharmacy Inc.
Version/Model Number
Mix Tampons CVS
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
HEB
Product Code Name
Tampon, Menstrual, Unscented
Public Device Record Key
852de115-5289-4a5e-b072-3dca9e9a5dfa
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
February 15, 2017
Package DI Number
30050428573182
Quantity per Package
12
Contains DI Package
00050428573181
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139 |
| U | Unclassified | 23 |