DEVICE: On-X Heart Valve Instruments (00851788001150)

Device Identifier (DI) Information

On-X Heart Valve Instruments
ONXI2-H
In Commercial Distribution
ONXI2-H
ON-X LIFE TECHNOLOGIES, INC.
00851788001150
GS1

1
844782318 *Terms of Use
Instrument Handle – all sizes. The instrument handle facilitates holding the valve or the rotator during surgery. The instrument handle is comprised of a grip, a bendable stem and a tip.
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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?
47683 Heart valve prosthesis sizer handle
A hand-held manual surgical instrument intended to be used during cardiac valve repair or replacement as a handle to which an interchangeable valve sizer is attached to allow the surgeon to evaluate the valve opening (patient annulus) into which the appropriate sized annuloplasty ring or replacement valve will be implanted. The device is typically made of metal and/or plastic (e.g., polysulphone) and is straight and/or curved, rigid and/or flexible in design; this handle may also be connected to the valve or ring holder to assist implantation. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DWS Instruments, Surgical, Cardiovascular
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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

cc460261-4fbe-45f7-9926-d2faf7b487ad
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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