Catalog Number

66-IT-15P

Brand Name

microTargeting™ Insertion Tube with Stylet

Version/Model Number

66-IT-15P-00821

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

641ac0a4-1d2a-4bde-94ce-dddb40f1b263

Public Version Date

December 09, 2020

Public Version Number

2

DI Record Publish Date

November 02, 2020

Package DI Number

10873263008215

Quantity per Package

5

Contains DI Package

00873263008218

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK/5