Identity
- Trade Name
- PROFILE 3D® FDA UDIPROFILE 3D™ FDA UDI
- Generic Name
- Mitral/tricuspid annuloplasty ring, open-surgery FDA UDIMitral annuloplasty ring FDA UDI
- Device Name
- RING 680R34 PROFILE 3D 26L MEXICO FDA UDIRING 680R34 PROFILE 3D 26L INSERT FDA UDI
- Model / Reference
- 680R34 FDA UDI
- Description
- RING 680R34 PROFILE 3D 26L MEXICO FDA UDIRING 680R34 PROFILE 3D 26L INSERT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994759214 FDA UDI00613994749420 FDA UDI
- 510(k) Number
- K073324 FDA UDI
- FDA Product Code
- KRH FDA UDI
- GMDN Term
- Mitral/tricuspid annuloplasty ring, open-surgery FDA UDIMitral annuloplasty ring FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDINot in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDIFDA 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 34.0 Millimeter FDA UDI
Category: Mitral/tricuspid annuloplasty ring, open-surgery
Profile 3d® by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mitral/tricuspid annuloplasty ring, open-surgery.
- CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL — Edwards Lifesciences LLC · Class II
- Séguin™ — ST. JUDE MEDICAL, INC. · Class II
- SJM Tailor™ — ST. JUDE MEDICAL, INC. · Class II
- Memo 4D — CORCYM SRL · Class II
- CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING — Edwards Lifesciences LLC · Class II
- Memo 4D — CORCYM SRL · Class II
- CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING — Edwards Lifesciences LLC · Class II
- CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL — Edwards Lifesciences LLC · Class II
Cleared under the same submission
K073324 also covers:
- PROFILE 3D® — MEDTRONIC, INC.
- PROFILE 3D® — MEDTRONIC, INC.
- PROFILE 3D® — MEDTRONIC, INC.
- PROFILE 3D® — MEDTRONIC, INC.
- PROFILE 3D® — MEDTRONIC, INC.
- PROFILE 3D® — MEDTRONIC, INC.
- PROFILE 3D® — MEDTRONIC, INC.
- PROFILE 3D® — MEDTRONIC, INC.
- Profile 3D™ — MEDTRONIC, INC.
- Profile 3D™ — MEDTRONIC, INC.
- Profile 3D™ — MEDTRONIC, INC.
- Profile 3D™ — MEDTRONIC, 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 |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (2)
- FDA UDI 0c452f10-0015-43a7-bceb-bc8e79cbb805 37 fields · synced Jun 1, 2026
- FDA UDI 1cd7a8c1-579d-4246-aef9-7567f8569fe0 38 fields · synced May 26, 2026