Catalog Number

100272A50.D V0

Brand Name

S4 OPTIK

Version/Model Number

SL 9800 5X digital

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K992836

Product Code

HJO

Product Code Name

Biomicroscope, Slit-Lamp, Ac-Powered

Public Device Record Key

4fdaadc6-8ca9-408c-b301-60c2bd444eb3

Public Version Date

April 08, 2022

Public Version Number

2

DI Record Publish Date

December 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-