Duns Number:012179121
Device Description: EvaCup menstrual cup is a soft device made of medical grade silicone. It is to be placed b EvaCup menstrual cup is a soft device made of medical grade silicone. It is to be placed by the user into the vagina to collect blood during menstruation.
Catalog Number
EVA002
Brand Name
EvaCup
Version/Model Number
Pink 2
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
HHE
Product Code Name
Cup, menstrual
Public Device Record Key
b4c75358-cd8c-465c-82ea-256c7a6f5e64
Public Version Date
July 07, 2020
Public Version Number
3
DI Record Publish Date
June 25, 2019
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |