Catalog Number

-

Brand Name

3.6V PROFESSIONAL STREAK LED RETINOSCOPE IN CASE

Version/Model Number

1302-P-1014-500

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

K893171

Product Code

HKL

Product Code Name

Retinoscope, Ac-Powered

Public Device Record Key

ad940cfd-6df5-4edf-b095-22108c948a6d

Public Version Date

March 06, 2020

Public Version Number

1

DI Record Publish Date

February 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-