FDA UDI
In Commercial Distribution
🇺🇸 United States
PERCEVAL PLUS
DI: 08022057015365
·
Model: PVF-S
·
CORCYM SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PERCEVAL PLUS
- Primary DI
- 08022057015365
- Version / Model
- PVF-S
- Catalog Number
- PVF-S
- Company Name
- CORCYM SRL
- Labeler DUNS
- 441454802
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-07
- Public Version
- 2
- Public Version Date
- 2025-05-22
- Public Version Status
- Update
- Public Device Record Key
- 9669c2fe-da3e-40f4-9f2e-90ac034ffac7
Device Description
SUTURELESS AORTIC HEART VALVE
Device Characteristics
- Single Use
- Yes
- 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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LWR | Heart-Valve, Non-Allograft Tissue | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60242 | Aortic open-surgery heart valve bioprosthesis | A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional aortic heart valve. It is processed to render the tissue in the valve non-viable; it may be tissue only, or tissue attached to a metal or synthetic polymer framework. The device is typically used to treat acquired or congenital valvular disease. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08022057015365 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P150011 | 013 |
| P150011 | 028 |