Catalog Number

-

Brand Name

GeoSource

Version/Model Number

GeoSource 2.0

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 17, 2021

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

-

Product Code

OLX

Product Code Name

Source Localization Software For Electroencephalograph Or Magnetoencephalograph

Public Device Record Key

9f8cf545-cd2c-4606-84c9-4c0e28230377

Public Version Date

January 31, 2022

Public Version Number

3

DI Record Publish Date

October 04, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-