Catalog Number

4741012991

Brand Name

FUJI MEDICAL X-RAY FILM

Version/Model Number

SUPER HR-U 28X35 500 E **

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

-

Product Code

IWZ

Product Code Name

Film, radiographic

Public Device Record Key

a35580f0-32ef-4c6a-9f4b-d2f198f0f506

Public Version Date

October 17, 2022

Public Version Number

1

DI Record Publish Date

October 07, 2022

Package DI Number

14547410129912

Quantity per Package

5

Contains DI Package

04547410129915

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box