Catalog Number

39-7428-2

Brand Name

JEDMED

Version/Model Number

39-7428-2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

HLI

Product Code Name

Ophthalmoscope, Ac-Powered

Public Device Record Key

2f9e3ba7-b5b0-406b-bf90-18d7fe56a6d3

Public Version Date

May 10, 2021

Public Version Number

4

DI Record Publish Date

December 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-