Identity
- Trade Name
- CardioGenesis FDA UDI
- Generic Name
- Transmyocardial revascularization laser system beam guide FDA UDI
- Device Name
- Pearl 5.0 Handpiece Delivery System FDA UDI
- Model / Reference
- HP-PRL5 FDA UDI
- Description
- Pearl 5.0 Handpiece Delivery System FDA UDI
Identifiers
- Catalog Number
- HP-PRL5 FDA UDI
- Primary DI / UDI-DI
- 00877234000119 FDA UDI
- PMA Number
- P970029 FDA UDI
- FDA Product Code
- MNO FDA UDI
- GMDN Term
- Transmyocardial revascularization laser system beam guide FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
CardioGenesis by Artivion, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P970029 also covers:
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
- Artivion, Inc.
Sources (1)
- FDA UDI 2785ad9d-59a7-435d-9e0b-de09dedf4bf9 38 fields · synced May 30, 2026