Catalog Number

-

Brand Name

Vitesse

Version/Model Number

4.0

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123152

Product Code

MUJ

Product Code Name

System,planning,radiation therapy treatment

Public Device Record Key

676ef560-1dc6-4093-9fbb-9f705727c3d7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-