Catalog Number

16482

Brand Name

HT 60/54 Plus 160W

Version/Model Number

FR71 T12 160W

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

012d2a16-88e8-4a1e-8b31-bcffa1a57999

Public Version Date

May 07, 2018

Public Version Number

1

DI Record Publish Date

April 04, 2018

Package DI Number

84014501003929

Quantity per Package

24

Contains DI Package

54014501403926

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pallet