Catalog Number

8-35-50100

Brand Name

Otometrics

Version/Model Number

1085, FACE CUSHION 2 ASM KIT

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

Product Code

GWN

Product Code Name

Nystagmograph

Public Device Record Key

8d13f29b-ead7-458c-8cc9-c574315ba94f

Public Version Date

December 03, 2020

Public Version Number

2

DI Record Publish Date

June 02, 2020

Package DI Number

05713315008566

Quantity per Package

10

Contains DI Package

05713315008474

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton box