Catalog Number

700-020832-00

Brand Name

Leksell Non-XY frame Mechanical Set KIT

Version/Model Number

2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K051830

Product Code

GZL

Product Code Name

Electrode, Depth

Public Device Record Key

987b968b-c5e3-47e9-83b2-53f4c66fd6fa

Public Version Date

February 25, 2021

Public Version Number

1

DI Record Publish Date

February 17, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-