Catalog Number

-

Brand Name

Panther Brachy

Version/Model Number

version 5.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 01, 2023

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

K032456,K143514,K984196

Product Code

MUJ

Product Code Name

System, Planning, Radiation Therapy Treatment

Public Device Record Key

c528ff54-ce75-4408-a4b3-418b5f9f9268

Public Version Date

July 12, 2018

Public Version Number

1

DI Record Publish Date

June 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-