On-X Heart Valve Instruments

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref ONXI3-21S

by On-X Life Technologies, Inc.

Identity

Trade Name: On-X Prosthetic Heart Valve Instrument Sizer EUDAMED
On-X Heart Valve Instruments FDA UDI
Generic Name: Heart valve annulus sizer, reusable FDA UDI
Device Name: On-X Prosthetic Heart Valve Instrument Sizer (Gold) EUDAMED
Aortic Sizers for valve size 21 (Gold).The sizers are used to gauge the resulting tissue annulus diameter after the annulus is prepared for implant. FDA UDI
Model / Reference: ONXI3-21S EUDAMEDFDA UDI
Description: Aortic Sizers for valve size 21 (Gold).The sizers are used to gauge the resulting tissue annulus diameter after the annulus is prepared for implant. FDA UDI

Identifiers

Catalog Number: ONXI3-21S FDA UDI
Primary DI / UDI-DI: 00851788001181 EUDAMEDFDA UDI
Basic UDI-DI: B-00851788001181 EUDAMED
FDA Product Code: DTI FDA UDI
EMDN Code: P07038001 HEART VALVE IMPLANT SIZERS EUDAMED
GMDN Term: Heart valve annulus sizer, reusable FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class I FDA UDI
Regulation Number: 870.3945 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

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 annulus sizer, reusable

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

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Also classified as Heart valve annulus sizer, reusable.

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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 fae6b442-0f18-429b-ba9c-0c52359f3e7d 37 fields · synced Jul 17, 2026
EUDAMED 1c72f067-8333-44d7-b82e-4532c1988634 61 fields · synced Jul 17, 2026