Catalog Number

66-IT-SG1P

Brand Name

microTargeting™ Insertion Tube with Stylet

Version/Model Number

66-IT-SG1P-00842

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

34d4acf7-9d5c-471c-9e6e-45592a6c2781

Public Version Date

November 05, 2021

Public Version Number

1

DI Record Publish Date

October 28, 2021

Package DI Number

10873263008420

Quantity per Package

5

Contains DI Package

00873263008423

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pk/5