Catalog Number

-

Brand Name

Leksell Gamma Knife Icon

Version/Model Number

1524411

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 18, 2018

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

Yes

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

03bac7f6-1434-48a2-9bb7-ac1f4f688e76

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-