Catalog Number

-

Brand Name

Leksell Gamma Knife Icon

Version/Model Number

1075251

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

-

Product Code

IWB

Product Code Name

System, radiation therapy, radionuclide

Public Device Record Key

6421045a-f112-427d-adb1-6552d3796b47

Public Version Date

April 05, 2021

Public Version Number

1

DI Record Publish Date

March 28, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-