Catalog Number

-

Brand Name

Sunmed

Version/Model Number

5-0239-85

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K131719

Product Code

HLJ

Product Code Name

Ophthalmoscope, Battery-Powered

Public Device Record Key

debc7c87-4d9d-4601-92a8-d344b379c1ea

Public Version Date

May 10, 2021

Public Version Number

5

DI Record Publish Date

September 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-