Catalog Number

31011

Brand Name

CLEO ADVANTAGE

Version/Model Number

F71T12 CLEO ADVANTAGE MAX 100W

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

31d035af-81ae-4faa-a77a-007244f036ac

Public Version Date

July 06, 2018

Public Version Number

1

DI Record Publish Date

June 05, 2018

Package DI Number

84014501004049

Quantity per Package

24

Contains DI Package

54014501404046

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pallet