Catalog Number

700-020832-00

Brand Name

Leksell Non-XY frame Mechanical Set Kit

Version/Model Number

Leksell Non-XY frame Mechanical Set KIT

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K051830

Product Code

GZL

Product Code Name

Electrode, Depth

Public Device Record Key

08717e13-e22b-4ab8-a2e3-e3ddfe871874

Public Version Date

June 09, 2020

Public Version Number

1

DI Record Publish Date

June 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-