Identity
- Trade Name
- CARBOMEDICS REDUCED FDA UDI
- Generic Name
- Aortic bi-leaflet mechanical heart valve prosthesis FDA UDI
- Model / Reference
- R5-027 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08022057012807 FDA UDI
- PMA Number
- P900060 FDA UDI
- FDA Product Code
- LWQ FDA UDI
- GMDN Term
- Aortic bi-leaflet mechanical heart valve prosthesis 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Aortic bi-leaflet mechanical heart valve prosthesis
Carbomedics Reduced by Corcym Srl — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Aortic bi-leaflet mechanical heart valve prosthesis.
- On-X Aortic Heart Valve with Conform-X Sewing Ring — ON-X LIFE TECHNOLOGIES, INC. · Class III
- Masters Series™ — ST. JUDE MEDICAL, INC. · Class III
- SJM™ Masters Series — ST. JUDE MEDICAL, INC. · Class III
- On-X Aortic Heart Valve with Standard Sewing Ring — ON-X LIFE TECHNOLOGIES, INC. · Class III
- Masters Series™ — ST. JUDE MEDICAL, INC. · Class III
- Masters Series™ — ST. JUDE MEDICAL, INC. · Class III
- Open Pivot™ — MEDTRONIC, INC. · Class III
- Open Pivot™ — MEDTRONIC, INC. · Class III
Cleared under the same submission
P900060 also covers:
- CARBOMEDICS — CORCYM SRL
- CARBOMEDICS CARBO-SEAL — CORCYM SRL
- CARBOMEDICS CARBO-SEAL — CORCYM SRL
- CARBOMEDICS CARBO-SEAL — CORCYM SRL
- CARBOMEDICS CARBO-SEAL — CORCYM SRL
- CARBOMEDICS CARBO-SEAL — CORCYM SRL
- CARBOMEDICS CARBO-SEAL — CORCYM SRL
- CARBOMEDICS CARBO-SEAL VALSALVA — CORCYM SRL
- CARBOMEDICS CARBO-SEAL VALSALVA — CORCYM SRL
- CARBOMEDICS CARBO-SEAL VALSALVA — CORCYM SRL
- CARBOMEDICS OPTIFORM — CORCYM SRL
- CARBOMEDICS OPTIFORM — CORCYM SRL
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 |
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Manufacturer
- Manufacturer
- Corcym Srl
Sources (1)
- FDA UDI 2314fd6c-d081-4b6e-bf61-4ea4228493f1 33 fields · synced May 30, 2026