Catalog Number

66-IT-IT1P

Brand Name

microTargeting™ Insertion Tube

Version/Model Number

66-IT-IT1P-00703

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

4db3f2ce-2ca0-4ae4-9d9c-c7c107ee4170

Public Version Date

October 22, 2018

Public Version Number

1

DI Record Publish Date

September 20, 2018

Package DI Number

10873263007034

Quantity per Package

5

Contains DI Package

00873263007037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK5