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On-X Heart Valve Instruments

FDA UDI

Class I (US FDA UDI)

by On-X Life Technologies, Inc.

Identity

Trade Name
On-X Heart Valve Instruments FDA UDI
Generic Name
Heart valve prosthesis repositioning tool FDA UDI
Device Name
Rotator For valve sizes 25. The valve rotator is used for reorienting an in-situ valve and may be used to verify leaflet mobility. FDA UDI
Model / Reference
ONXI2-25R FDA UDI
Description
Rotator For valve sizes 25. The valve rotator is used for reorienting an in-situ valve and may be used to verify leaflet mobility. FDA UDI

Identifiers

Catalog Number
ONXI2-25R FDA UDI
Primary DI / UDI-DI
00851788001051 FDA UDI
FDA Product Code
DWS FDA UDI
GMDN Term
Heart valve prosthesis repositioning tool FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
870.4500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Heart valve prosthesis repositioning tool

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

Similar devices

Also classified as Heart valve prosthesis repositioning tool.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
On-X Life Technologies, Inc.

Sources (1)

  • FDA UDI fcd793d9-cb44-4805-9190-682e029d305d 37 fields · synced May 30, 2026