Catalog Number

FC1021

Brand Name

microTargeting™ Array Electrode Carrier and Clamp

Version/Model Number

FC1021-00061

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 13, 2018

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

K011775

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Public Device Record Key

96251f76-9f26-4b0b-93ad-e03d3825c606

Public Version Date

July 16, 2018

Public Version Number

4

DI Record Publish Date

August 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-