Catalog Number

1101617

Brand Name

X-OMAT MX Developer and Replenisher

Version/Model Number

X-OMAT MX Developer and Replenisher

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 25, 2020

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

IWZ

Product Code Name

Film, radiographic

Public Device Record Key

a976e6af-b42f-4798-b3ae-54d8a3d99085

Public Version Date

June 05, 2020

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-