Duns Number:089780961
Device Description: VOXAPOD menstrual cup small is a uniquely designed device that collects menstrual flow rat VOXAPOD menstrual cup small is a uniquely designed device that collects menstrual flow rather than absorbing it. It is a cup-like receptacle placed by the user into the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. It is a small, soft device made of a biocompatible synthetic material (e.g., silicone elastomer) and is normally available [non-prescription] over-the-counter (OTC). It is typically removed from the vagina by breaking the suction seal and pulling on the stem and/or base. The device can function as an alternative to tampons. This is a reusable device.
Catalog Number
-
Brand Name
VOXAPOD
Version/Model Number
VP-Cup-Sm-C
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"
Yes
For Single-Use
-
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
8d23d751-11a0-4cef-80f2-2f9ff1254029
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
May 13, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |