Catalog Number

-

Brand Name

Panther TPS

Version/Model Number

v5.6

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

October 30, 2024

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,K083502,K101076,K193459,K984196

Product Code

MUJ

Product Code Name

System, Planning, Radiation Therapy Treatment

Public Device Record Key

333f0107-4d8b-423a-86fa-b33f2fd477a8

Public Version Date

November 09, 2021

Public Version Number

1

DI Record Publish Date

November 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-