Catalog Number

103700

Brand Name

RADIANCE

Version/Model Number

HP 400-500W R7s

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

9181f5f2-9d68-4a15-a078-5fef56192ad9

Public Version Date

March 10, 2020

Public Version Number

1

DI Record Publish Date

March 02, 2020

Package DI Number

B5331037001

Quantity per Package

25

Contains DI Package

B5331037000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton box