Catalog Number

-

Brand Name

Landers Wide Field Temporary Keratoprosthesis 8.2mm

Version/Model Number

OLTK 8.2

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K910828

Product Code

MLP

Product Code Name

Keratoprosthesis, Temporary Implant, Surgical Use

Public Device Record Key

7d69faf2-3fff-4a56-b322-fb7f1c4f8e78

Public Version Date

October 17, 2018

Public Version Number

4

DI Record Publish Date

December 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-