Catalog Number

66-DA-FT-03

Brand Name

WayPoint™ Fiducial Placement Template

Version/Model Number

66-DA-FT-03-00839

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 20, 2022

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

K092192,K092192

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Public Device Record Key

b1c9ed12-e387-431a-b8d9-4047854828cd

Public Version Date

January 21, 2022

Public Version Number

3

DI Record Publish Date

June 22, 2021

Package DI Number

10873263008390

Quantity per Package

10

Contains DI Package

00873263008393

Package Discontinue Date

-

Package Status

Not in Commercial Distribution

Package Type

-