DEVICE: DR 14s C DX-D IMAGING PACKAGE (05414904222201)

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Device Identifier (DI) Information

DR 14s C DX-D IMAGING PACKAGE
5400/523
XBOOK
Agfa HealthCare NV
05414904222201
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
X-ray system digital converter A portable mains electricity (AC-powered) device intended to retrofit an analogue x-ray [i.e., screen-film, computerized radiography (plate)] system with a direct flat panel detector in order to convert an analogue x-ray system into a digital x-ray system using the same modality components. It is typically an electronic box which is integrated into the analogue x-ray system via wired connections to each of the components (i.e., generator, exposure button, workstation and detector), whereby it synchronizes the original analogue generator with the direct flat panel detector. It is intended to be operated by a healthcare professional in a clinical setting and may include integrated software.
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FDA Product Code

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Product Code Product Code Name
MQB Solid state x-ray imager (flat panel/digital imager)
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Width: 35 Centimeter
Length: 43 Centimeter
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Device Status

In Commercial Distribution
December 23, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
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No
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No CLOSE

Customer Contact

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+1(877)777-2432
salesinfo@agfa.com
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