Catalog Number

-

Brand Name

HRT3

Version/Model Number

Rostock Cornea Module SW V1.5a

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

-

Product Code

MXK

Product Code Name

Device,Analysis,Anterior Segment

Public Device Record Key

ca722be9-eee6-4419-bec6-11bda00d90a5

Public Version Date

April 08, 2022

Public Version Number

3

DI Record Publish Date

July 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-