Identity
- Trade Name
- Alair™ FDA UDI
- Generic Name
- Radio-frequency ablation system FDA UDI
- Device Name
- RF Controller Accessory Kit FDA UDI
- Model / Reference
- M005ATS20110 FDA UDI
- Description
- RF Controller Accessory Kit FDA UDI
Identifiers
- Catalog Number
- M005ATS20110 FDA UDI
- Primary DI / UDI-DI
- 08714729802778 FDA UDI
- PMA Number
- P080032 FDA UDI
- FDA Product Code
- OOY FDA UDI
- GMDN Term
- Radio-frequency ablation 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radio-frequency ablation system
Alair™ by Boston Scientific — 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
- Boston Scientific
Sources (1)
- FDA UDI eb823c18-bf1b-4784-aaf9-1b374327f6f1 35 fields · synced Jun 8, 2026