FDA UDI
In Commercial Distribution
🇺🇸 United States
On-X Heart Valve Instruments
DI: 00851788001006
·
Model: ONXI2-CK
·
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
- 00851788001006
- Version / Model
- ONXI2-CK
- Catalog Number
- ONXI2-CK
- 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
- 2023-08-08
- Public Version
- 1
- Public Version Date
- 2023-08-16
- Public Version Status
- New
- Public Device Record Key
- 54f3e95f-a32e-4b07-a916-27d31b645251
Device Description
Instrument Kit Aortic and Mitral (Grey).The instrument kit contains the sizers and a rotators for each size of the On-X® Prosthetic Heart Valve and On-X® Ascending Aortic Prosthesis. A universal instrument handle and leaflet probe are also included. The instruments are reusable.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| OFA | Cardiovascular Surgical Instruments Tray | Cardiovascular | 870.4500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62687 | Heart valve repair/prosthesis implantation kit | A collection of dedicated instruments intended to be used during heart valve repair and/or implantation of a heart valve prosthesis during an open surgical procedure. The kit typically includes two or more of the following: annulus sizers, rulers (e.g., aortic valve cusp ruler), a handle, repositioning tool, and a valve tester, which may be arranged in a sterilizable instrument tray. Implantable devices (e.g., heart valve prosthesis) are not included in the kit. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851788001006 | GS1 |
Customer Contacts
- Phone
- 15123398039
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- stored in a clean, cool and dry environment.