Catalog Number

8500051

Brand Name

iZoom Loupes

Version/Model Number

8500051

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FSP

Product Code Name

Loupe, Diagnostic/Surgical

Public Device Record Key

5ba90af6-3bfe-4631-b957-69690b715bd9

Public Version Date

January 25, 2022

Public Version Number

2

DI Record Publish Date

August 09, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-