Catalog Number

S-SMB-20

Brand Name

MeLuna

Version/Model Number

Sport Sapphire Ball Medium Standard

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K140626

Product Code

HHE

Product Code Name

Cup, Menstrual

Public Device Record Key

58d9623d-2421-4c16-a9e1-fbac52640b67

Public Version Date

July 07, 2020

Public Version Number

4

DI Record Publish Date

November 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-