Perceval Dual Collapser Base
by Corcym S.r.l. Italy EUDAMEDGUDID
Ref ICV1232Model Dual Collapser Base
Product code LWREMDN L070799
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number8022057ACCBASEC3 | Date29 Apr 2026 | StatusActive |
| United States | GUDID listing GUDID | Number08022057014917 | Date6 Jun 2016 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Recalls
-
- Terminated Z-0716-2017
Sorin Group USA, Inc. announces a voluntary field action for the Perceval Sutureless Heart Valve due to updated steps associated with the implantation procedure.
Specification
- Trade Name
- Perceval Dual Collapser Base EUDAMEDPerceval S GUDID
- Generic Name
- Self-expandable heart valve prosthesis collapsing tool base
- Model / Reference
- Dual Collapser Base, ICV1232
- Primary DI / UDI-DI
- 08022057014917
- Basic UDI-DI
- 8022057ACCBASEC3
- Direct Marketing DI
- 08022057014917
- FDA Product Code
- LWR
- EMDN Code
- L070799 Cardiac surgery instruments, reusable - other
- GMDN Term
- Self-expandable heart valve prosthesis collapsing tool base
- Device Class
- Class I EUDAMEDClass III GUDID
- Market of Registration
- Italy
- Commercial Distribution
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class III |
Manufacturer details
- EUDAMED SRN
- IT-MF-000027865
Other devices from Corcym S.r.l.
Properties & raw data
Show properties, registry sources and raw records
Other properties (21)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No
Sources (2)
- EUDAMED f96505da-4ee6-4126-bc5a-7dc622ccdaa2
- FDA UDI 98267b8a-9da3-45b3-bce8-42293bbbe3c9