Catalog Number

31866

Brand Name

smartSunlight

Version/Model Number

FRW75 T12 smartSunlight1914R 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

f7ac9d20-1dca-46d5-bfd6-070b39073c78

Public Version Date

December 24, 2019

Public Version Number

1

DI Record Publish Date

December 16, 2019

Package DI Number

54014501504210

Quantity per Package

25

Contains DI Package

04014501004210

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tertiary Packaging