FDA Registration
Active
🇺🇸 United States
Navilyst Medical Convenience Kit
Reg #: 1319639
·
FEI: 1000138054
·
Expires 2025
Products
1
Proprietary Names
10
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 |
|---|---|---|---|---|---|
| Angiography/Angioplasty Kit | OEQ | Class 2 | Cardiovascular | No | 2017-04-26 |
Proprietary Names
Navilyst Medical Convenience Kit
K05 Inflation Kit
K07 Syringe Kit (multiple K06)
K12 (Procedure Kit)
K22C Vein Tray
K02 Syringe Kit (multiple K01)
K19 Combination Packs
K23C Vein Accessory Kit
convenience kit
10Fore Hemostasis Valve (MAP)
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)