Catalog Number

U1LED100G21

Brand Name

EVERLUX LIGHT SOURCE

Version/Model Number

R00

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

-

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

NTN

Product Code Name

Led Light Source

Public Device Record Key

b11204ec-57aa-41c1-b882-22874338eea3

Public Version Date

May 13, 2022

Public Version Number

1

DI Record Publish Date

May 05, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-