Identity
- Trade Name
- CardioGenesis FDA UDI
- Generic Name
- Transmyocardial revascularization solid-state laser system FDA UDI
- Device Name
- SolarGen 2100s Holmium:YAG Laser Console FDA UDI
- Model / Reference
- NS2000 FDA UDI
- Description
- SolarGen 2100s Holmium:YAG Laser Console FDA UDI
Identifiers
- Catalog Number
- LSR-SG2100S FDA UDI
- Primary DI / UDI-DI
- 00877234000096 FDA UDI
- PMA Number
- P970029 FDA UDI
- FDA Product Code
- MNO FDA UDI
- GMDN Term
- Transmyocardial revascularization solid-state laser system FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Transmyocardial revascularization solid-state laser system
CardioGenesis by Artivion, Inc. — Class III — 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 III | Pending data |
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Manufacturer
- Manufacturer
- Artivion, Inc.
Sources (1)
- FDA UDI 2a86def5-155e-4651-89ae-8ffe840a37dd 37 fields · synced Jun 1, 2026