Duns Number:424319460
Device Description: A Menstrual cup is a receptacle placed in the vagina to collect menstrual flow
Catalog Number
-
Brand Name
MCUK Menstrual Cup Size B (NP)
Version/Model Number
Size B
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
-
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
K060852
Product Code
HHE
Product Code Name
Cup, Menstrual
Public Device Record Key
aa23c424-7e68-4e32-8a97-f1dbe2aa580b
Public Version Date
July 07, 2020
Public Version Number
2
DI Record Publish Date
July 01, 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. | 3 |