Identity
- Trade Name
- TransForm McCarthy Annuloplasty Ring FDA UDI
- Generic Name
- Mitral/tricuspid annuloplasty ring, open-surgery FDA UDI
- Device Name
- Annuloplasty Ring FDA UDI
- Model / Reference
- TF-34 FDA UDI
- Description
- Annuloplasty Ring FDA UDI
Identifiers
- Primary DI / UDI-DI
- B040TF340 FDA UDI
- 510(k) Number
- K232599 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
- 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Mitral/tricuspid annuloplasty ring, open-surgery
TransForm McCarthy Annuloplasty Ring by Genesee Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mitral/tricuspid annuloplasty ring, open-surgery.
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- Memo 4D — CORCYM SRL · Class II
- CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING — Edwards Lifesciences LLC · Class II
Cleared under the same submission
K232599 also covers:
- TransForm McCarthy Annuloplasty Ring — GENESEE BIOMEDICAL, INC.
- TransForm McCarthy Annuloplasty Ring — GENESEE BIOMEDICAL, INC.
- TransForm McCarthy Annuloplasty Ring — GENESEE BIOMEDICAL, INC.
- TransForm McCarthy Annuloplasty Ring — GENESEE BIOMEDICAL, INC.
- TransForm McCarthy Annuloplasty Ring — GENESEE BIOMEDICAL, INC.
- TransForm McCarthy Annuloplasty Ring — GENESEE BIOMEDICAL, INC.
- TransForm McCarthy Annuloplasty Ring — GENESEE BIOMEDICAL, INC.
- TransForm McCarthy Annuloplasty Ring — GENESEE BIOMEDICAL, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Genesee Biomedical, Inc.
Sources (1)
- FDA UDI 3012a2a8-0863-4bf2-83d1-2f1d0b2ca6f4 35 fields · synced Jun 8, 2026