FDA UDI
In Commercial Distribution
🇺🇸 United States
On-X Heart Valve Instruments
DI: 00851788001150
·
Model: ONXI2-H
·
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
- 00851788001150
- Version / Model
- ONXI2-H
- Catalog Number
- ONXI2-H
- 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
- cc460261-4fbe-45f7-9926-d2faf7b487ad
Device 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.
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 |
|---|---|---|---|---|
| 47683 | Heart valve prosthesis sizer handle | A hand-held manual surgical instrument intended to be used during cardiac valve repair or replacement as a handle to which an interchangeable valve sizer is attached to allow the surgeon to evaluate the valve opening (patient annulus) into which the appropriate sized annuloplasty ring or replacement valve will be implanted. The device is typically made of metal and/or plastic (e.g., polysulphone) and is straight and/or curved, rigid and/or flexible in design; this handle may also be connected to the valve or ring holder to assist implantation. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851788001150 | GS1 |
Customer Contacts
- Phone
- 1-5123398039
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- stored in a clean, cool and dry environment.