Catalog Number

1030758

Brand Name

Leksell Gamma Knife Icon

Version/Model Number

1539744

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

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

ab870d42-0397-48c0-8ea7-f8a12f18f548

Public Version Date

November 01, 2019

Public Version Number

3

DI Record Publish Date

September 16, 2018

Package DI Number

07340048304917

Quantity per Package

10

Contains DI Package

07340048311588

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-