Catalog Number

12-199001

Brand Name

PORTRAY

Version/Model Number

DD.02.00

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)

-

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

c3efa2e1-fab0-4ee4-8479-47e312038480

Public Version Date

December 23, 2021

Public Version Number

1

DI Record Publish Date

December 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-