Catalog Number

700-54520-001

Brand Name

iVue

Version/Model Number

iVue 100

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

e51d68b1-b094-49cf-9217-6717761810bd

Public Version Date

September 01, 2020

Public Version Number

1

DI Record Publish Date

August 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-