Catalog Number

32264 / 3230076201

Brand Name

smartSunlight

Version/Model Number

FR75T12 smartSunlight 1974 R /180W

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

f5bb9967-989d-4c93-b2a1-ea6b94b4565c

Public Version Date

June 30, 2021

Public Version Number

1

DI Record Publish Date

June 22, 2021

Package DI Number

54014501504616

Quantity per Package

25

Contains DI Package

04014501004616

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tertiary Packaging