Catalog Number

66-IT-1028

Brand Name

microTargeting™ Insertion Tube

Version/Model Number

66-IT-1028-00397

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

Yes

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,K011775

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Public Device Record Key

def07a87-0013-4eb5-ba7f-73e03fef0384

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 17, 2016

Package DI Number

10873263003975

Quantity per Package

5

Contains DI Package

00873263003978

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK/5