FDA Registration
Active
🇨🇦 Canada
STYLET
Reg #: 9611665
·
FEI: 3002807095
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics EO Canada, Inc.
- Registration Number
- 9611665
- FEI Number
- 3002807095
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 400 Ambassador Drive
- City
- Mississauga Ontario
- Country
- CA
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 |
|---|---|---|---|---|---|
| Catheter, Peritoneal | GBW | Class 1 | General, Plastic Surgery | No | 2014-07-08 |
Proprietary Names
STYLET
Peritoneoscopic or Laparoscopic Peritoneal Dialysis Catheter Implantation Systems
Laparoscopic Peritoneal Dialysis Catheter Implantation System
Percutaneous Peritoneal Dialysis Catheter Implantation Systems
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)