Catalog Number

103303A00 V0/S10

Brand Name

S4 OPTIK

Version/Model Number

COBRA

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

K132987

Product Code

HKI

Product Code Name

Camera, Ophthalmic, Ac-Powered

Public Device Record Key

e9804c6c-ea0b-48a2-9063-f78ad8c97489

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-