Catalog Number

26510

Brand Name

RADIANCE

Version/Model Number

FR71T12 / RADIANCE R2 07017 / 200W

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LEJ

Product Code Name

Booth, Sun Tan

Public Device Record Key

16bbc094-d52a-4b98-b279-a5ce945f9794

Public Version Date

January 21, 2022

Public Version Number

1

DI Record Publish Date

January 13, 2022

Package DI Number

54014501404640

Quantity per Package

24

Contains DI Package

04014501004647

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tertiary Packaging