Catalog Number

-

Brand Name

GN Otometrics A/S

Version/Model Number

Disposable Electrode 24" Wired Qty 10

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K061791

Product Code

GWN

Product Code Name

Nystagmograph

Public Device Record Key

48033649-82da-41ee-8c7f-ab7f1cb20452

Public Version Date

December 03, 2020

Public Version Number

7

DI Record Publish Date

September 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-