Identity
- Trade Name
- Synergy™ Ablation System FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation system generator FDA UDI
- Device Name
- Ablation and Sensing Unit FDA UDI
- Model / Reference
- ASU2 FDA UDI
- Description
- Ablation and Sensing Unit FDA UDI
Identifiers
- Catalog Number
- A000019 FDA UDI
- Primary DI / UDI-DI
- 00818354010206 FDA UDI
- PMA Number
- P100046 FDA UDI
- FDA Product Code
- OCM 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
No
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
Synergy™ Ablation System by Atricure, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Atricure, Inc.
Sources (1)
- FDA UDI 439019f3-d0e1-4690-8ccf-685c8009a6db 37 fields · synced Jun 8, 2026