Duns Number:604286695
Device Description: Size 1 Standard with Blue Cleaning Case
Catalog Number
-
Brand Name
myEverCup
Version/Model Number
26X0ARWN1KZ20F2N9PK2CS8B5H
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HHE
Product Code Name
Cup, Menstrual
Public Device Record Key
c54b20ab-90af-4407-b652-37569bda2e96
Public Version Date
September 15, 2020
Public Version Number
3
DI Record Publish Date
August 04, 2020
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 65 |