Catalog Number

103600

Brand Name

RADIANCE

Version/Model Number

HP 600-650W GY9.5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

905adb21-549e-4cc5-bd26-587e08abc940

Public Version Date

March 10, 2020

Public Version Number

1

DI Record Publish Date

March 02, 2020

Package DI Number

B5331036001

Quantity per Package

25

Contains DI Package

B5331036000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton box