Catalog Number

32546 / 3230076181

Brand Name

extraSunlight

Version/Model Number

FRW68T12 / extraSunlight 1711R / 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

f237e19b-7abd-45b5-bf9d-d2b8710d5ae3

Public Version Date

April 19, 2022

Public Version Number

1

DI Record Publish Date

April 11, 2022

Package DI Number

54014501304674

Quantity per Package

6

Contains DI Package

04014501004678

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

tertiary packaging