Catalog Number

1285.1

Brand Name

Eckardt temporary keratoprosthesis, Ø 7 mm, 2.8 mm depth

Version/Model Number

1285.1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 12, 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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MLP

Product Code Name

Keratoprosthesis, Temporary Implant, Surgical Use

Public Device Record Key

b271b797-3d6d-44e3-a91d-1cccb65dabe0

Public Version Date

January 13, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-