Catalog Number

903304340-0

Brand Name

3.3 VHO

Version/Model Number

FR71T12 3.3 VHO 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

97c2cbcc-fb4a-40b5-9e5c-03ad13fec07c

Public Version Date

December 12, 2019

Public Version Number

2

DI Record Publish Date

June 19, 2018

Package DI Number

84014501004063

Quantity per Package

20

Contains DI Package

54014501404060

Package Discontinue Date

December 10, 2019

Package Status

Not in Commercial Distribution

Package Type

Pallet