Identity
- Trade Name
- CARBOMEDICS ANNULOFLO FDA UDI
- Generic Name
- Mitral/tricuspid annuloplasty ring, open-surgery FDA UDI
- Model / Reference
- AR-730 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08022057013682 FDA UDI
- 510(k) Number
- K021051 FDA UDI
- FDA Product Code
- KRH FDA UDI
- GMDN Term
- Mitral/tricuspid annuloplasty ring, open-surgery FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3800 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
MR Conditional FDA UDI
Carbomedics Annuloflo by Corcym Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Corcym Inc.
Sources (1)
- FDA UDI 7b593486-ed8d-4ce3-8fb4-21ffa850f8db 34 fields · synced Jun 6, 2026