Catalog Number

26682

Brand Name

Radiance R2 XLP 1.7

Version/Model Number

FR71T12 100-120W

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

f97635cc-1b6f-4a3e-981f-49a03a722840

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 22, 2017

Package DI Number

84014501003554

Quantity per Package

24

Contains DI Package

54014501403551

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pallet