Catalog Number

C0243

Brand Name

Waypoint™ Navigator

Version/Model Number

C0243-00786

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

-

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

K092192

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Public Device Record Key

62faec0a-a00b-4457-8e9c-f69ae8e4159d

Public Version Date

March 30, 2020

Public Version Number

2

DI Record Publish Date

February 26, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-