FDA Registration
Active
🇨🇦 Canada
TheraSphere Administration Set
Reg #: 8022247
·
FEI: 3001092088
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BWXT MEDICAL LTD.
- Registration Number
- 8022247
- FEI Number
- 3001092088
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 447 MARCH RD.
- City
- OTTAWA Ontario
- Country
- CA
Owner / Operator
- Firm Name
- BWXT MEDICAL LTD.
- Operator Number
- 10061054
- Address
- 447 March Road, Mail Stn 7A
- City
- Ottawa
- State
- Ontario
- Postal Code
- K2K 1X8
- Country
- CA
- Correspondent
- Tapashi Dasgupta
US Agent
- Business Name
- PARAXEL INTERNATIONAL
- Contact Name
- ALLY DANTA
- Address
- 2520 Meridian Parkway,, Suite 200
- City
- Durham
- State
- NC
- ZIP
- 27713
- Country
- US
- [email protected]
- Phone
- 978 3132406
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Applicator, Radionuclide, Manual | IWJ | Class 1 | Radiology | No | 2024-11-15 |
Proprietary Names
TheraSphere Administration Set
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)