Catalog Number

091480108-AGFA

Brand Name

EDITOR HFe

Version/Model Number

801

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

IZO

Product Code Name

Generator, High-Voltage, X-Ray, Diagnostic

Public Device Record Key

7a087254-0475-4e96-a69b-b45cf71ad913

Public Version Date

March 12, 2019

Public Version Number

1

DI Record Publish Date

March 04, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-