DEVICE: Foot and Ankle Stand (00860008892768)

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Device Record History
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Device Identifier (DI) Information
Foot and Ankle Stand
G1
In Commercial Distribution

OXOS Medical, Inc.
00860008892768
GS1

1
080323883 *Terms of Use
No description.
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Device Characteristics
MR Unsafe
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?
65313 Diagnostic X-ray system positioning frame
An electrically-powered component of a diagnostic x-ray system intended to be placed on the floor to position and support a patient, an x-ray tube assembly, and an image receptor assembly (bucky) during a diagnostic x-ray procedure. It typically consists of a patient table, floor stands for the x-ray tube and image receptor, and controls. The table and floor stands may be moved and/or tilted; the image receptor may be included, however the x-ray tube is not included.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
IYB Tube Mount, X-Ray, Diagnostic
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes 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 55 Degrees Celsius
Special Storage Condition, Specify: Altitude: Between 1000 ft below sea level and 8,000 ft above sea level
Handling Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Storage Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
2e7b0b2e-c610-4797-9e12-b6be925a37d5
June 10, 2025
1
June 02, 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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