Catalog Number

-

Brand Name

GN Otometrics A/S

Version/Model Number

ABR Electrode Cable

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 01, 2018

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

K122067

Product Code

GWJ

Product Code Name

Stimulator, Auditory, Evoked Response

Public Device Record Key

341107a4-acec-45fb-8912-3a41b989b1c7

Public Version Date

December 03, 2020

Public Version Number

5

DI Record Publish Date

September 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-