Catalog Number

-

Brand Name

Casco Cup

Version/Model Number

Mid 1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 19, 2021

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)

-

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

96802eaf-bbbd-4c00-ba5c-29373bf5bb18

Public Version Date

December 03, 2021

Public Version Number

3

DI Record Publish Date

October 13, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-