Duns Number:062312574
Device Description: Multi pack of 36 tampons 8 Light, 20 Regular and 8 Super Absorbency
Catalog Number
-
Brand Name
CVS Health Tampons
Version/Model Number
BCVSGC36
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
HIL
Product Code Name
Tampon, Menstrual, Scented, Deodorized
Public Device Record Key
f7a88223-1336-42b9-80a8-aea5b3fa537f
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 20, 2016
Package DI Number
10050428352301
Quantity per Package
12
Contains DI Package
00050428352304
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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139 |
| U | Unclassified | 23 |