Duns Number:344349290
Device Description: The portable and fully digital X-ray system Amadeo M-DR mini is for use for first aid serv The portable and fully digital X-ray system Amadeo M-DR mini is for use for first aid services, intensive care units, emergency departments, as well as ships and mobile hospitals (e.g. container solutions) in inaccessible areas, in laboratories and scientific stations in remote parts of the world. The Amadeo M-DR mini is used for wireless digital X-ray imaging. The Amadeo M-AX Version does not contain wireless flat panel detector.
Catalog Number
AM1000
Brand Name
Amadeo M-DR mini
Version/Model Number
Amadeo M-AX
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)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
afdb528b-9fa2-477e-94fc-bf6e05756f0f
Public Version Date
January 07, 2019
Public Version Number
1
DI Record Publish Date
December 05, 2018
Package DI Number
04250802902910
Quantity per Package
1
Contains DI Package
04250802902880
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Transport Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |