FDA UDI
In Commercial Distribution
🇺🇸 United States
On-X Heart Valve Instruments
DI: 00851788001044
·
Model: ONXI2-23R
·
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
- 00851788001044
- Version / Model
- ONXI2-23R
- Catalog Number
- ONXI2-23R
- 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
- 74f56f3a-69dc-434f-b835-bae27dfecff5
Device Description
Rotator For valve size 23. The valve rotator is used for reorienting an in-situ valve and may be used to verify leaflet mobility.
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 |
|---|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | 870.4500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62685 | Heart valve prosthesis repositioning tool | A hand-held manual surgical instrument intended to be used to realign or reposition a heart valve prosthesis after initial insertion and positioning with a heart valve prosthesis holder. The device may be a one-piece instrument or attached to a separate handle, and is available in a range of configurations for the aortic, mitral, or tricuspid heart valve. It is typically made of plastic materials. 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 | 00851788001044 | GS1 |
Customer Contacts
- Phone
- 5123398039
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 23mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- stored in a clean, cool and dry environment.