Catalog Number

-

Brand Name

The Morgan Lens

Version/Model Number

MT2000

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"

Yes

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

KYG

Product Code Name

Device, irrigation, ocular surgery

Public Device Record Key

98415c76-5025-48a4-b3d7-8ef5dfaa170f

Public Version Date

June 21, 2021

Public Version Number

1

DI Record Publish Date

June 13, 2021

Package DI Number

M17011

Quantity per Package

12

Contains DI Package

M170MT20000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box