DEVICE: ArtPIX DRF (07290012104909)

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Device Record History
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Device Identifier (DI) Information
ArtPIX DRF
63627589
In Commercial Distribution

C.M.T. MEDICAL TECHNOLOGIES LTD.
07290012104909
GS1

1
600084453 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
37679 Stationary general-purpose fluoroscopic x-ray system, digital
A stationary general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be viewed in both real-time and delayed format.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JAA System, X-Ray, Fluoroscopic, Image-Intensified
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K202235 000
No CLOSE

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
No Device Sizes
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Device Record Status
b8bac88d-f280-4dd8-a06c-35929f530437
October 26, 2020
1
October 18, 2020
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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
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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