Catalog Number

MS20

Brand Name

Molteno M-Sphere

Version/Model Number

MS20

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

Yes

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

HPZ

Product Code Name

Implant, Eye Sphere

Public Device Record Key

de3e4da6-e454-4c83-9c1b-c854ca2e3c1b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-