Catalog Number

3XA7L

Brand Name

M Plus - Half Blue

Version/Model Number

M PLUS-HALF BLUE 28x35

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)

Yes

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

14d63856-3512-46be-a0de-9875af8af8ad

Public Version Date

November 01, 2022

Public Version Number

1

DI Record Publish Date

October 24, 2022

Package DI Number

05414904220405

Quantity per Package

5

Contains DI Package

05414904028605

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-