Catalog Number

31865

Brand Name

smartSunlight

Version/Model Number

FRW71 T12 smartSunlight 1804R 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

f56406cc-16da-4e96-a878-0b62b14a0de4

Public Version Date

January 28, 2020

Public Version Number

1

DI Record Publish Date

January 20, 2020

Package DI Number

54014501504227

Quantity per Package

25

Contains DI Package

04014501004227

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tertiary Packaging