FDA UDI
In Commercial Distribution
🇺🇸 United States
On-X Heart Valve Instruments
DI: 00851788001099
·
Model: ONXI2-21S
·
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
- 00851788001099
- Version / Model
- ONXI2-21S
- Catalog Number
- ONXI2-21S
- 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
- 0affa23f-5236-490d-8976-40a8897c0c19
Device Description
Aortic Sizers for valve size 21(grey).The sizers are used to gauge the resulting tissue annulus diameter after the annulus is prepared for implant.
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 |
|---|---|---|---|---|
| DTI | Sizer, Heart-Valve, Prosthesis | Cardiovascular | 870.3945 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47684 | Heart valve annulus sizer, reusable | A hand-held manual surgical instrument intended to be used during heart valve repair or replacement that enables evaluation of the valve opening (patent annulus) into which the appropriately sized annuloplasty ring or replacement valve will be implanted. It is typically available as a set of round tapered sizers in a range for the aortic, mitral, or tricuspid valve; it may include an attachable handle which may also be used 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 | 00851788001099 | GS1 |
Customer Contacts
- Phone
- 512-339-8039
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 21mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- stored in a clean, cool and dry environment.