Catalog Number

-

Brand Name

Optomed Aurora full set

Version/Model Number

60100635A

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

K180378

Product Code

HKI

Product Code Name

Camera, Ophthalmic, Ac-Powered

Public Device Record Key

f8b24d28-ab53-442c-b62a-aa426244386b

Public Version Date

November 23, 2021

Public Version Number

2

DI Record Publish Date

December 04, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-