Catalog Number

5606013 US

Brand Name

Clement Clarke Ophthalmic

Version/Model Number

5606013 US

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"

Yes

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

K953965

Product Code

HJO

Product Code Name

Biomicroscope, Slit-Lamp, Ac-Powered

Public Device Record Key

49f129b0-0af3-4592-9388-4db37bed0b86

Public Version Date

April 08, 2022

Public Version Number

4

DI Record Publish Date

July 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-