Catalog Number

10332-1

Brand Name

COSMOLUX LSR / 25W

Version/Model Number

FR25 T5 25W PH / BiPin

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

633a17af-2508-4cc8-8466-1136d6f812ad

Public Version Date

January 22, 2021

Public Version Number

4

DI Record Publish Date

June 09, 2017

Package DI Number

54014501500229

Quantity per Package

25

Contains DI Package

04014501000229

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tertiary Packaging