FDA Registration
Active
🇬🇧 United Kingdom
Vapr CoolPulse Curve Suction Electrode
Reg #: 9617070
·
FEI: 3002807134
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GYRUS MEDICAL LTD.
- Registration Number
- 9617070
- FEI Number
- 3002807134
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- FORTRAN RD., ST. MELLONS
- City
- CARDIFF Wales
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K143475
Owner / Operator
- Firm Name
- ATL Technology LLC
- Operator Number
- 10045899
- Address
- 1335 West 1650 North
- City
- Springville
- State
- UT
- Postal Code
- 84663
- Country
- US
US Agent
- Business Name
- ATL Technology
- Contact Name
- Lauren Cordova
- Address
- 1335 West 1650 North
- City
- Springville
- State
- UT
- ZIP
- 84663
- Country
- US
- [email protected]
- Phone
- 801 8534035 ext. 235
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2023-05-05 |
Proprietary Names
Vapr CoolPulse Curve Suction Electrode
Vapr Tripolar 90 Suction Electrode
Vapr CoolPulse Curve Suction Electrode XL
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)