Catalog Number

32065

Brand Name

pureSunlight

Version/Model Number

FR71T12 / pureSunlight 1825R / 160W

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

834b0d60-183c-450e-ae79-5c55b688f2bb

Public Version Date

May 11, 2022

Public Version Number

1

DI Record Publish Date

May 03, 2022

Package DI Number

54014501504685

Quantity per Package

25

Contains DI Package

04014501004685

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

tertiary packaging