FDA Registration
Active
🇺🇸 United States
ACTC1025 COOLTIP RFA Cluster Electrode Kit 10X2.5
Reg #: 1724474
·
FEI: 3003094851
·
Expires 2025
Products
1
Proprietary Names
18
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Terumo BCT STERILIZATION SERVICES, Inc.
- Registration Number
- 1724474
- FEI Number
- 3003094851
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11308 W Collins Ave
- City
- LAKEWOOD
- State
- CO
- ZIP
- 80215
- Country
- US
Regulatory Submissions
- 510(k) Number
- K973297
Owner / Operator
- Firm Name
- Terumo BCT, INC.
- Operator Number
- 9002708
- Address
- 10811 WEST COLLINS AVE., --
- City
- Lakewood
- State
- CO
- Postal Code
- 80215
- Country
- US
- Correspondent
- Corrine Lucas
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2013-02-13 |
Proprietary Names
ACTC1025 COOLTIP RFA Cluster Electrode Kit 10X2.5
ACT1030 COOLTIP RFA Single Electrode Kit 10X3
SWCT1530 RFA Two Electrodes Kit SWCT1530
ACT530 COOLTIP RFA Single Electrode Kit 15X3
ACT2530 COOLTIP RFA Single Electrode Kit 25X3
ACT1507 COOLTIP RFA Single Electrode Kit 15X0.7
SWCT2530 RFA Switching Electrode Kit SWCT2530
SWCT1540 RFA Switching Electrode Kit SWCT1540
ACTC1525 COOLTIP RFA Cluster Electrode Kit 15X2.5
ACT1510 COOLTIP RFA Single Electrode Kit 15X1
ACTC2025 COOLTIP RFA Cluster Electrode 20X2.5 KIT
ACT2020 COOLTIP RFA Single Electrode Kit 20X2
SWCT25303 RFA Switching Electrode Kit SWCT25303
SWCT15303 RFA Switching Electrode Kit SWCT15303
ACT1520 COOLTIP RFA Single Electrode Kit 15X2
ACT2030 COOLTIP RFA Single Electrode Kit 20X3
ACT1020 COOLTIP RFA Single Electrode Kit 10X2
SWCT2540 RFA Switching Electrode Kit SWCT2540
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)