Catalog Number

32380 / 3230076219

Brand Name

smartSunlight

Version/Model Number

FRW71T12 / smartSunlight 1816 R / 160W

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

22545f51-1e98-4925-8530-7a239d990549

Public Version Date

September 12, 2022

Public Version Number

1

DI Record Publish Date

September 02, 2022

Package DI Number

54014501504708

Quantity per Package

25

Contains DI Package

04014501004708

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tertiary Packaging