MCUK Menstrual Cup Size B (NP) - A Menstrual cup is a receptacle placed in the - MOONCUP LTD

Duns Number:424319460

Device Description: A Menstrual cup is a receptacle placed in the vagina to collect menstrual flow

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More Product Details

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

Product Characteristics

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 Details

Product Code

HHE

Product Code Name

Cup, Menstrual

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MOONCUP LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3