FDA Registration
Active
🇺🇸 United States
Navilyst Medical Convenience Kit
Reg #: 1319639
·
FEI: 1000138054
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S., LLC
- Registration Number
- 1319639
- FEI Number
- 1000138054
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 84 Park Rd
- City
- Queensbury
- State
- NY
- ZIP
- 12804
- Country
- US
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 |
|---|---|---|---|---|---|
| Cardiovascular Procedure Kit | OEZ | Class 2 | Cardiovascular | No | 2017-05-03 |
Proprietary Names
Navilyst Medical Convenience Kit
Multiple Terumo Cardiovascular Procedure Kit
K11 Pressure Monitoring Kit
K17 Interventional Kit
K09 Manifold Kit
Kits
VASCULAR CATH INSERTION KIT
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)