Catalog Number

6402001ULUS

Brand Name

Clement Clarke Ophthalmic

Version/Model Number

6402001ULUS

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

-

Product Code

HJQ

Product Code Name

Stereoscope, Ac-Powered

Public Device Record Key

d45469fc-f4df-44a3-8688-6e11405f1c1a

Public Version Date

August 09, 2019

Public Version Number

3

DI Record Publish Date

July 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-