FDA Registration
Active
🇺🇸 United States
LSO2556 (TM) - RFA-06022 Sonata Radiofrequency Ablation Handpiece
Reg #: 2030624
·
FEI: 3000206435
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Isomedix Operations, Inc.
- Registration Number
- 2030624
- FEI Number
- 3000206435
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 43425 Business Park Dr
- City
- Temecula
- State
- CA
- ZIP
- 92590
- Country
- US
Regulatory Submissions
- 510(k) Number
- K193516
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 1527821
- Address
- 5960 Heisley Rd, --
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | KNF | Class 2 | Obstetrics/Gynecology | No | 2022-06-30 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2022-06-30 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2022-06-30 |
Proprietary Names
LSO2556 (TM) - RFA-06022 Sonata Radiofrequency Ablation Handpiece
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)