Catalog Number

66-IT(FP4)

Brand Name

microTargeting™ Insertion Tube

Version/Model Number

66-IT(FP4)-00665

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

K011775

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Public Device Record Key

32d88f58-2468-4db0-99f8-959082c379b1

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-