Catalog Number

31001

Brand Name

RIO Bronze

Version/Model Number

FR79T12 RIO Bronze SHR 2000 180W

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

33bf2bed-f45c-4ef1-9f06-632f11e7fe75

Public Version Date

June 04, 2018

Public Version Number

1

DI Record Publish Date

May 02, 2018

Package DI Number

84014501003974

Quantity per Package

24

Contains DI Package

54014501403988

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pallet