Duns Number:207651758
Device Description: Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by t Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
Catalog Number
DV002
Brand Name
The DivaCup
Version/Model Number
Model 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
e8e0512f-01f8-4cc6-8d7b-1397e95ca5ad
Public Version Date
July 28, 2021
Public Version Number
6
DI Record Publish Date
July 27, 2017
Package DI Number
10857538000043
Quantity per Package
60
Contains DI Package
00857538000022
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |