Catalog Number

-

Brand Name

NA

Version/Model Number

170538-00

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K121448,K132816

Product Code

MUJ

Product Code Name

System, planning, radiation therapy treatment

Public Device Record Key

e27b5ce1-fb7f-4c60-a71c-d96b8ca81710

Public Version Date

January 21, 2019

Public Version Number

1

DI Record Publish Date

December 19, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-