Identity
- Trade Name
- CARBOMEDICS OPTIFORM FDA UDI
- Generic Name
- Mitral bi-leaflet mechanical heart valve prosthesis FDA UDI
- Model / Reference
- F7-025 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08022057012845 FDA UDI
- PMA Number
- P900060 FDA UDI
- FDA Product Code
- LWQ FDA UDI
- GMDN Term
- Mitral 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: Mitral bi-leaflet mechanical heart valve prosthesis
Carbomedics Optiform by Corcym Srl — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mitral bi-leaflet mechanical heart valve prosthesis.
- Masters Series™ — ST. JUDE MEDICAL, INC. · Class III
- Masters Series™ — ST. JUDE MEDICAL, INC. · Class III
- SJM™ Masters Series — ST. JUDE MEDICAL, INC. · Class III
- CARBOMEDICS OPTIFORM — Corcym Inc. · Class III
- SJM™ Masters Series — ST. JUDE MEDICAL, INC. · Class III
- Open Pivot™ — MEDTRONIC, INC. · Class III
- Open Pivot™ — MEDTRONIC, INC. · Class III
- SJM™ Masters Series — ST. JUDE MEDICAL, 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 f1bb435d-50ac-42e5-bfb9-70d89bd4e488 33 fields · synced May 30, 2026