Catalog Number

66-MP-EH

Brand Name

WayPoint™ Entry Offset Mounting Hub

Version/Model Number

66-MP-EH-00726

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

K092562,K092562

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Public Device Record Key

a4a50290-370f-4b29-af00-1007a52b738b

Public Version Date

June 15, 2021

Public Version Number

3

DI Record Publish Date

December 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-