FDA Registration
Active
🇬🇧 United Kingdom
Electrosurgical cutting and coagulation device and accessories THERMAFLEX END EFFECT (FLEX THERMAL END EFFECT)
Reg #: 3015219237
·
FEI: 3015219237
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STERIGENICS UK LIMITED
- Registration Number
- 3015219237
- FEI Number
- 3015219237
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Plot 13a, Seymour Link Road
- City
- Markham Vale Derbyshire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K974022
Owner / Operator
- Firm Name
- Sotera Health LLC
- Operator Number
- 10029425
- Address
- 2015 Spring Road, Suite 650
- City
- Oak Brook
- State
- IL
- Postal Code
- 60523
- Country
- US
- Correspondent
- Karen Whaley-Krumins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2013-03-18 |
Proprietary Names
Electrosurgical cutting and coagulation device and accessories THERMAFLEX END EFFECT (FLEX THERMAL END EFFECT)
Electrosurgical cutting and coagulation device and accessories THERMAFLEX SIDE EFFECT (FLEX THERMAL SIDE EFFECT)
Electrosurgical cutting and coagulation device and accessories VAPRFLEX END EFFECT (FLEX END EFFECT)
VAPR® Flexible End Effect Electrode 3.5 mm x 160 mm
VAPR® Flexible Side Effect Electrode 3.5 mm x 160 mm
Electrosurgical cutting and coagulation device and accessories THERMAL ANGLED END (VAPR T THERMAL ANGLED END)
Electrosurgical cutting and coagulation device and accessories VAPRFLEX SIDE EFFECT (FLEX SIDE EFFECT)
Electrosurgical cutting and coagulation device and accessories THERMAL REV ANGLED SIDE (VAPR T THERMAL REV ANGLED SIDE)
Electrosurgical cutting and coagulation device and accessories THERMAL SIDE
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)