Duns Number:314629130
Device Description: Darkroom automated x-ray film processor
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
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 24 |