Identity
- Trade Name
- On-X Heart Valve Instruments FDA UDI
- Generic Name
- Heart valve prosthesis tester, reusable FDA UDI
- Device Name
- The leaflet probe (all sizes) is a flexible rod with tapered ends. The leaflet probe may be used to gently move the leaflets to verify that they open and close freely. FDA UDI
- Model / Reference
- ONXI2-LP FDA UDI
- Description
- The leaflet probe (all sizes) is a flexible rod with tapered ends. The leaflet probe may be used to gently move the leaflets to verify that they open and close freely. FDA UDI
Identifiers
- Catalog Number
- ONXI2-LP FDA UDI
- Primary DI / UDI-DI
- 00851788001167 FDA UDI
- FDA Product Code
- LXN FDA UDI
- GMDN Term
- Heart valve prosthesis tester, reusable 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
Moist Heat or Steam Sterilization FDA UDI
Category: Heart valve prosthesis tester, reusable
On-X Heart Valve Instruments by On-X Life Technologies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- FDA UDI e962d785-6230-456a-a021-8ccd86ea8d7b 36 fields · synced May 30, 2026