Identity
- Trade Name
- Maestro 4000™ Controller FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation system generator FDA UDI
- Device Name
- RF Cardiac Ablation Controller FDA UDI
- Model / Reference
- M0044000H0 FDA UDI
- Description
- RF Cardiac Ablation Controller FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729861935 FDA UDI
- FDA Product Code
- LPB FDA UDIOAD FDA UDI
- GMDN Term
- Percutaneous radio-frequency ablation system generator 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: Percutaneous radio-frequency ablation system generator
Maestro 4000™ Controller by Boston Scientific — Class III — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific
Sources (2)
- FDA UDI 4aa81a09-04b9-4b6c-a1a0-c21c955fa154 33 fields · synced May 30, 2026
- EUDAMED 1 fields · synced May 29, 2026