Venus Cup - Venus S Cup Violet - CASCO BAY MOLDING LTD.

Duns Number:604286695

Device Description: Venus S Cup Violet

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More Product Details

Catalog Number

-

Brand Name

Venus Cup

Version/Model Number

S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2021

Issuing Agency

In HIBCC

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HHE

Product Code Name

Cup, Menstrual

Device Record Status

Public Device Record Key

e85aff75-de1f-4856-93d6-9155133d18b0

Public Version Date

December 31, 2021

Public Version Number

3

DI Record Publish Date

January 25, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CASCO BAY MOLDING LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 65