Duns Number:080294990
Device Description: Cora Tampons, DTC, App. Light 5/Reg. 6/Super 5
Catalog Number
-
Brand Name
Cora
Version/Model Number
02Tampons-105
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
K191431,K191431
Product Code
HEB
Product Code Name
Tampon, Menstrual, Unscented
Public Device Record Key
30204029-23f9-4005-bbd1-1f3d0fe83229
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 27, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |