Catalog Number

-

Brand Name

Leksell Gamma Knife Icon

Version/Model Number

1526778

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

d5dff36d-cec3-445d-9749-d59ebc55d079

Public Version Date

November 01, 2019

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

07340048304610

Quantity per Package

20

Contains DI Package

07340048304627

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-