FDA Registration
Active
🇨🇦 Canada
SWE Vial Shield G10V
Reg #: 3016739098
·
FEI: 3016739098
·
Expires 2025
Products
1
Proprietary Names
16
Establishment Types
5
Classifications
1
Registration Details
- Registration Name
- SOUTH WEST EXPOSURES (2566031 ONT INC.)
- Registration Number
- 3016739098
- FEI Number
- 3016739098
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 523-50 Curzon Street
- City
- Toronto Ontario
- Country
- CA
Owner / Operator
- Firm Name
- South West Exposures (2566031 ONT Inc.)
- Operator Number
- 10070366
- Address
- 523-50 Curzon Street
- City
- Toronto
- State
- Ontario
- Postal Code
- M4M 0C2
- Country
- CA
- Correspondent
- Robert Kamen
US Agent
- Business Name
- Sirona Complete Care
- Contact Name
- Jenette Garbarz
- Address
- 3006 W Middleton Road
- City
- Columbiana
- State
- OH
- ZIP
- 44408
- Country
- US
- [email protected]
- Phone
- 330 4234410
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Shield, Vial | IWW | Class 1 | Radiology | No | 2020-04-16 |
Proprietary Names
SWE Vial Shield G10V
SWE Vial Shield T30V
SWE Vial Shield Y90V
SWE Vial Shield T10V
SWE Vial Grip VG-001
SWE HiCap accessory
SWE Vial shield Y90S (SWE-EP1402-001)
F18BULK50
Pb20V
AcV20sf
50Vsf
PbV25R
SWE Vial shield G30V
AcV20
TTS20
AcV100
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device