Catalog Number

6000-390-000

Brand Name

CranialMask Tracker

Version/Model Number

6000-390-000

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

-

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Public Device Record Key

f5bc6c02-0211-4141-80c6-5c8192b561cb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 13, 2017

Package DI Number

37613327097628

Quantity per Package

5

Contains DI Package

07613327097627

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack