Catalog Number

1186-3-4000

Brand Name

ECOMAX

Version/Model Number

1186

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 16, 2019

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

IXW

Product Code Name

Processor, Radiographic-Film, Automatic

Public Device Record Key

b3240e8d-e266-4550-b11a-eed7868e0a32

Public Version Date

December 17, 2019

Public Version Number

3

DI Record Publish Date

October 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-