Catalog Number

005.0785

Brand Name

neuromate tool guide

Version/Model Number

Tool guide OD15 - Microdrive FHC stardrive - Leksell

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

K132755

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Public Device Record Key

b0e10fba-e129-4f54-804b-1634074da597

Public Version Date

April 08, 2022

Public Version Number

4

DI Record Publish Date

December 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-