Catalog Number

-

Brand Name

Sunmed

Version/Model Number

9-7005-00

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)

Yes

Over the Counter (OTC)

-

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

b33e946b-2230-48c4-a7ab-218d80b694bd

Public Version Date

May 10, 2021

Public Version Number

5

DI Record Publish Date

October 03, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-