Catalog Number

-

Brand Name

Elements Trajectory Planning

Version/Model Number

2.5

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K113732,K211544

Product Code

HAW

Product Code Name

Neurological Stereotaxic Instrument

Public Device Record Key

ee3a4c5b-5dbd-41f5-ae4e-54e8df1b162c

Public Version Date

November 18, 2021

Public Version Number

2

DI Record Publish Date

March 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-