Identity
- Trade Name
- On-X Prosthetic Heart Valve Instrument Handle EUDAMEDOn-X Heart Valve Instruments FDA UDI
- Generic Name
- Heart valve prosthesis sizer handle FDA UDI
- Device Name
- On-X Prosthetic Heart Valve Instrument Handle EUDAMEDInstrument 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. FDA UDI
- Model / Reference
- ONXI2-H EUDAMEDFDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- ONXI2-H FDA UDI
- Primary DI / UDI-DI
- 00851788001150 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00851788001150 EUDAMED
- FDA Product Code
- DWS FDA UDI
- EMDN Code
- P07038003 MECHANICAL HEART VALVE IMPLANT ACCESSORIES EUDAMED
- GMDN Term
- Heart valve prosthesis sizer handle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 870.4500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Moist Heat or Steam Sterilization FDA UDI
Category: Heart valve prosthesis sizer handle
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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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 cc460261-4fbe-45f7-9926-d2faf7b487ad 36 fields · synced Jun 19, 2026
- EUDAMED ffdfddd7-cf00-474b-9f79-be47e55fccfa 61 fields · synced Jun 19, 2026