Catalog Number

66-IT-ME1P

Brand Name

microTargeting™ Insertion Tube

Version/Model Number

66-IT-ME1P-00858

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

2ba9e50a-ce42-46e3-83ca-22d16e37e3c1

Public Version Date

June 16, 2022

Public Version Number

1

DI Record Publish Date

June 08, 2022

Package DI Number

10873263008581

Quantity per Package

5

Contains DI Package

00873263008584

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK/5