DEVICE: On-X Heart Valve Instruments (00851788001747)

Device Identifier (DI) Information

On-X Heart Valve Instruments
ONXI3-CT
In Commercial Distribution
ONXI3-CT
ON-X LIFE TECHNOLOGIES, INC.
00851788001747
GS1

1
844782318 *Terms of Use
The instrument tray (Gold) is optional and may be used for storage and transportation of On-X® Heart Valve instruments. The tray can withstand steam sterilization and instruments may be sterilized in this tray.
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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?
12143 Instrument tray, reusable
A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OFA Cardiovascular Surgical Instruments Tray
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: stored in a clean, cool and dry environment.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

fbda8953-4005-435d-ab35-96d90ebbfca8
August 17, 2023
1
August 09, 2023
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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

[?]
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)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
1-5123398039
onx@onxlti.com
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