Catalog Number

16121

Brand Name

GENESIS 170WRS-E / 160W

Version/Model Number

FR71 T12 160W VHO PH / BP

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

48fb52b5-ada2-45d7-9fa1-b8d082122307

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 09, 2017

Package DI Number

84014501000539

Quantity per Package

24

Contains DI Package

54014501400536

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pallet