Catalog Number

-

Brand Name

Grason-Stadler

Version/Model Number

GSI Audera Pro

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

-

Product Code

GWJ

Product Code Name

Stimulator, Auditory, Evoked Response

Public Device Record Key

4dd58401-0ed6-434c-8a0d-d3e07a234ca0

Public Version Date

November 04, 2020

Public Version Number

1

DI Record Publish Date

October 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-