Catalog Number

1529980

Brand Name

Leksell GammaPlan

Version/Model Number

1529604

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 01, 2018

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

-

Product Code

IWB

Product Code Name

System, radiation therapy, radionuclide

Public Device Record Key

b1f44554-4828-4e8e-b94f-66307f232417

Public Version Date

August 12, 2019

Public Version Number

5

DI Record Publish Date

April 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-