DEVICE: Cart (00860008892737)

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Device Record History
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Device Identifier (DI) Information
Cart
K1
In Commercial Distribution

OXOS Medical, Inc.
00860008892737
GS1

1
080323883 *Terms of Use
No description.
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Device Characteristics
MR Unsafe
No
Yes
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?
37658 Hand-held basic diagnostic x-ray system, digital
An assembly of devices that comprise a digital general-purpose hand-held diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture and display and manipulation. It typically operates on battery power and is designed to be easily carried from location to location by a single operator. It is most commonly used in sports medicine or military applications. It consists of a modular configuration that can be upgraded by the addition of hardware or software components and/or accessories. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OWB Interventional Fluoroscopic X-Ray System
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
IZL System, X-Ray, Mobile
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K241567 000
No CLOSE

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

[?]
Storage and Handling
Handling Environment Temperature: between 0 and 29.9 Degrees Celsius
Storage Environment Temperature: between -10 and 40 Degrees Celsius
Special Storage Condition, Specify: Altitude: Between 0 ft below sea level and 8,000 ft above sea level
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
7c096aab-3117-4909-808b-9490b0dd33a7
January 09, 2025
1
January 01, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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