Panther Brachy - PROWESS, INC.

Duns Number:002162728

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More Product Details

Catalog Number

-

Brand Name

Panther Brachy

Version/Model Number

version 5.0

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2018

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

MUJ

Product Code Name

System,Planning,Radiation Therapy Treatment

Device Record Status

Public Device Record Key

c68fa972-720e-478a-b687-2556124741d0

Public Version Date

June 12, 2018

Public Version Number

3

DI Record Publish Date

April 28, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PROWESS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 8