Catalog Number

700-48578-004

Brand Name

iVue

Version/Model Number

iVue 100-2

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K121739

Product Code

HLI

Product Code Name

Ophthalmoscope, Ac-Powered

Public Device Record Key

9a70ab68-9194-4c84-a873-4b31de0e6910

Public Version Date

June 05, 2020

Public Version Number

4

DI Record Publish Date

August 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-