FDA UDI
In Commercial Distribution
🇺🇸 United States
On-X Heart Valve Instruments
DI: 00851788001167
·
Model: ONXI2-LP
·
ON-X LIFE TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- On-X Heart Valve Instruments
- Primary DI
- 00851788001167
- Version / Model
- ONXI2-LP
- Catalog Number
- ONXI2-LP
- Company Name
- ON-X LIFE TECHNOLOGIES, INC.
- Labeler DUNS
- 844782318
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-09
- Public Version
- 1
- Public Version Date
- 2023-08-17
- Public Version Status
- New
- Public Device Record Key
- e962d785-6230-456a-a021-8ccd86ea8d7b
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXN | Probe, Test, Heart-Valve | Cardiovascular | 870.4500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62684 | Heart valve prosthesis tester, reusable | A pen-like device intended to be used to manually manipulate a heart valve prosthesis to perform an assessment of the valvular prosthesis (e.g., its ability to open and close) prior to implantation and/or when in situ. It typically has a handle made of plastic and a soft tip (e.g., made of rubber) to prevent damage of the valvular prosthesis. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851788001167 | GS1 |
Customer Contacts
- Phone
- 15123398039
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- stored in a clean, cool and dry environment.