Catalog Number

32416 / 3230076262

Brand Name

smartSunlight

Version/Model Number

FRW79T12 / smartSunlight 2025 R / 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

b1b6024a-32ea-4569-ab6a-02fa7acaecaa

Public Version Date

February 22, 2022

Public Version Number

1

DI Record Publish Date

February 14, 2022

Package DI Number

54014501504654

Quantity per Package

25

Contains DI Package

04014501004654

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tertiary Packaging