Identity
- Trade Name
- CARBOMEDICS FDA UDI
- Generic Name
- Heart valve prosthesis holder, reusable FDA UDI
- Model / Reference
- AR-150 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08022057014016 FDA UDI
- PMA Number
- P900060 FDA UDI
- FDA Product Code
- LWQ FDA UDI
- GMDN Term
- Heart valve prosthesis holder, reusable FDA UDI
Classification
- Device Class
- Class III 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
No
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 prosthesis holder, reusable
Carbomedics by Corcym Srl — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Heart valve prosthesis holder, reusable.
- HEART VALVE ACCESSOR — Edwards Lifesciences LLC · Class I
- HEART VALVE HANDLE ACCESSORY — Edwards Lifesciences LLC · Class I
- 1141M MITRIS RESILIA Mitral Valve Handle — Edwards Lifesciences LLC · Class I
- A HANDLE COMPATIBLE WITH RING HOLDERS MODELS 5100, 4900, 4100, 4200, 4450 AND 46 — Edwards Lifesciences LLC · Class I
- HEART VALVE ACCESSOR — Edwards Lifesciences LLC · Class I
- Open Pivot™ — MEDTRONIC, INC. · Class I
- FLEXIBLE HANDLE — Edwards Lifesciences LLC · Class I
- Open Pivot™ — MEDTRONIC, INC. · Class I
Cleared under the same submission
P900060 also covers:
- 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
- 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 01d7ed09-f6f9-4a89-8b21-74c6b4886334 33 fields · synced Jun 1, 2026