Catalog Number

8-35-39300

Brand Name

Otometrics

Version/Model Number

1085, FACE PAD ASSEMBLY KIT V2

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

K122550,K122550,K122550

Product Code

GWN

Product Code Name

Nystagmograph

Public Device Record Key

414220ce-d16b-43e2-bc51-9253a9d3d18d

Public Version Date

December 03, 2020

Public Version Number

2

DI Record Publish Date

May 18, 2020

Package DI Number

05713315008504

Quantity per Package

12

Contains DI Package

05713315008467

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton