Identity
- Trade Name
- Perceval RELYON PAK FDA UDI
- Generic Name
- Heart valve prosthesis holder, single-use FDA UDI
- Device Name
- Perceval RELYON PAK Size S FDA UDI
- Model / Reference
- PAK-S FDA UDI
- Description
- Perceval RELYON PAK Size S FDA UDI
Identifiers
- Catalog Number
- PAK-S FDA UDI
- Primary DI / UDI-DI
- 08022057015532 FDA UDI
- PMA Number
- P150011 FDA UDI
- FDA Product Code
- LWR FDA UDI
- GMDN Term
- Heart valve prosthesis holder, single-use FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Heart valve prosthesis holder, single-use
Perceval RELYON PAK by Corcym Srl — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Heart valve prosthesis holder, single-use.
- Perceval RELYON PAK — Corcym Inc. · Class III
- SJM™ — ST. JUDE MEDICAL, INC. · Class I
- Masters Series™ — ST. JUDE MEDICAL, INC. · Class I
- Masters Series™ — ST. JUDE MEDICAL, INC. · Class I
- PERCEVAL S — Corcym Inc. · Class III
- Perceval RELYON PAK — Corcym Inc. · Class III
- DISPOSABLE HANDLE FOR VALVES/SIZERS — Edwards Lifesciences LLC · Class I
- SJM™ — ST. JUDE MEDICAL, INC. · Class I
Cleared under the same submission
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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Corcym Srl
Sources (1)
- FDA UDI 19e25ba2-675c-434e-8247-48273b996eec 35 fields · synced May 30, 2026