Catalog Number

66-IT-MR3

Brand Name

microTargeting™ Insertion Tube

Version/Model Number

66-IT-MR3-00803

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 06, 2020

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

2aa49e47-5373-446c-89fd-8bee38fe3f21

Public Version Date

January 07, 2020

Public Version Number

2

DI Record Publish Date

August 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-