Catalog Number

-

Brand Name

EzRay Air

Version/Model Number

VEX-P300

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

-

Product Code

EHD

Product Code Name

Unit, X-Ray, Extraoral With Timer

Public Device Record Key

b5156e4b-8eba-4a70-a223-78028974f0b0

Public Version Date

June 22, 2021

Public Version Number

3

DI Record Publish Date

March 09, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-