Catalog Number

26506

Brand Name

CosmoLux

Version/Model Number

FR71T12 CosmoLux Lynx S4 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

e03c3ac5-db0c-4f35-a95b-e01b32832397

Public Version Date

June 25, 2018

Public Version Number

1

DI Record Publish Date

May 25, 2018

Package DI Number

54014501404015

Quantity per Package

24

Contains DI Package

04014501004012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tertiary Packaging