Identity
- Trade Name
- PERCEVAL S FDA UDI
- Generic Name
- Heart valve annulus sizer, reusable FDA UDI
- Model / Reference
- ICV1219 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08022057014733 FDA UDI
- FDA Product Code
- DTI FDA UDI
- GMDN Term
- Heart valve annulus sizer, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 870.3945 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Heart valve annulus sizer, reusable
Perceval S by Corcym Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Heart valve annulus sizer, reusable.
- Trifecta™ — ST. JUDE MEDICAL, INC. · Class I
- Hancock™ II — MEDTRONIC, INC. · Class I
- Tailor™ & Attune™ — ST. JUDE MEDICAL, INC. · Class I
- Dafodil™ Pericardial Bioprosthesis Valve — Meril Life Sciences Pvt. Ltd. · Class III
- Freestyle™ 7990 — MEDTRONIC, INC. · Class I
- Medtronic Open Pivot™ — MEDTRONIC, INC. · Class I
- Tri-Ad™ — MEDTRONIC, INC. · Class I
- MOSAIC™ — MEDTRONIC, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Corcym Srl
Sources (1)
- FDA UDI 734c549d-7e0c-4e8f-b221-6eabcc01c1b5 32 fields · synced May 30, 2026