DEVICE: Allia (00195278485168)

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Device Identifier (DI) Information
Allia
IGS 3
In Commercial Distribution
5874604
GE MEDICAL SYSTEMS
00195278485168
GS1

1
266062561 *Terms of Use
Allia IGS3 UDI
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
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?
37623 Stationary angiographic x-ray system, digital
A stationary diagnostic fluoroscopic x-ray system specifically designed to optimize the capability of users to visually and quantitatively evaluate the anatomy and function of blood vessels of the heart, brain and other organs, as well as the lymphatic system. It uses digital techniques for real-time image capture, display and manipulation and typically includes spot-film capabilities in addition to the fluoroscopic features. It is commonly used in conjunction with an injected x-ray contrast medium during either imaging or x-ray guided surgical or interventional procedures. Images can be viewed in both real-time and delayed formats.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JAA System, x-ray, fluoroscopic, image-intensified
OWB Interventional fluoroscopic x-ray system
IZI System, x-ray, angiographic
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K181403 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 103 KiloPascal
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
59914a9e-ec0b-4adb-8f02-18c57effc7ef
February 28, 2024
2
April 08, 2022
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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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