Catalog Number

-

Brand Name

EzRay Air W

Version/Model Number

VEX-S300W

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

K163705

Product Code

EHD

Product Code Name

Unit, X-Ray, Extraoral With Timer

Public Device Record Key

7e9b02a3-49e4-4529-9d23-c74f969f4fdf

Public Version Date

June 22, 2021

Public Version Number

2

DI Record Publish Date

March 25, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-