Catalog Number

-

Brand Name

Enova Illumination

Version/Model Number

80034-006

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

ced8c65b-6926-4431-a7e5-97d5e5ed9f89

Public Version Date

February 04, 2022

Public Version Number

1

DI Record Publish Date

January 27, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-