Catalog Number

-

Brand Name

Merge Eye Station

Version/Model Number

11.6.1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K913929

Product Code

HKI

Product Code Name

Camera, Ophthalmic, Ac-Powered

Public Device Record Key

29dfacc9-9675-439a-b4ba-5f7607922360

Public Version Date

June 21, 2019

Public Version Number

6

DI Record Publish Date

December 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-