On-X Heart Valve Instruments

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref ONXI2-CK

by On-X Life Technologies, Inc.

Identity

Trade Name: On-X Prosthetic Heart Valve Instrument Kit EUDAMED
On-X Heart Valve Instruments FDA UDI
Generic Name: Heart valve repair/prosthesis implantation kit FDA UDI
Device Name: On-X Prosthetic Heart Valve Instrument Kit (Grey) EUDAMED
Instrument Kit Aortic and Mitral (Grey).The instrument kit contains the sizers and a rotators for each size of the On-X® Prosthetic Heart Valve and On-X® Ascending Aortic Prosthesis. A universal instrument handle and leaflet probe are also included. The instruments are reusable. FDA UDI
Model / Reference: ONXI2-CK EUDAMEDFDA UDI
Description: Instrument Kit Aortic and Mitral (Grey).The instrument kit contains the sizers and a rotators for each size of the On-X® Prosthetic Heart Valve and On-X® Ascending Aortic Prosthesis. A universal instrument handle and leaflet probe are also included. The instruments are reusable. FDA UDI

Identifiers

Catalog Number: ONXI2-CK FDA UDI
Primary DI / UDI-DI: 00851788001006 EUDAMEDFDA UDI
Basic UDI-DI: B-00851788001006 EUDAMED
FDA Product Code: OFA FDA UDI
EMDN Code: P07038003 MECHANICAL HEART VALVE IMPLANT ACCESSORIES EUDAMED
GMDN Term: Heart valve repair/prosthesis implantation kit FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class I FDA UDI
Regulation Number: 870.4500 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Heart valve repair/prosthesis implantation kit

On-X Heart Valve Instruments by On-X Life Technologies, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Heart valve repair/prosthesis implantation kit.

On-X Heart Valve Instruments — ON-X LIFE TECHNOLOGIES, INC. · Class I

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: On-X Life Technologies, Inc.

Sources (2)

FDA UDI 54f3e95f-a32e-4b07-a916-27d31b645251 36 fields · synced Jun 19, 2026
EUDAMED 1667e886-e704-4222-af65-7ad737071322 61 fields · synced Jun 19, 2026