Identity
- Trade Name
- Physio Flex Annuloplasty Ring FDA UDI
- Generic Name
- Mitral/tricuspid annuloplasty ring, open-surgery FDA UDI
- Device Name
- Physio Flex Annuloplasty Ring FDA UDI
- Model / Reference
- 5300 FDA UDI
- Description
- Physio Flex Annuloplasty Ring FDA UDI
Identifiers
- Catalog Number
- 5300M30 FDA UDI
- Primary DI / UDI-DI
- 00690103206197 FDA UDI
- 510(k) Number
- K192762 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
No
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
Physio Flex Annuloplasty Ring by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K192762 also covers:
- Physio Flex Annuloplasty Ring — Edwards Lifesciences LLC
- Physio Flex Annuloplasty Ring — Edwards Lifesciences LLC
- Physio Flex Annuloplasty Ring — Edwards Lifesciences LLC
- Physio Flex Annuloplasty Ring — Edwards Lifesciences LLC
- Physio Flex Annuloplasty Ring — Edwards Lifesciences LLC
- Physio Flex Annuloplasty Ring — Edwards Lifesciences LLC
- Physio Flex Annuloplasty Ring — Edwards Lifesciences LLC
- Physio Flex Annuloplasty Ring — Edwards Lifesciences LLC
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
- Edwards Lifesciences LLC
Sources (1)
- FDA UDI 8ad7031d-4af3-4642-adc6-bf75e9597978 38 fields · synced Jun 8, 2026