FDA Registration
Active
🇺🇸 United States
Irrigating Syringe
Reg #: 2029275
·
FEI: 1000306431
·
Expires 2025
Products
1
Proprietary Names
14
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S., LLC
- Registration Number
- 2029275
- FEI Number
- 1000306431
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 344 Bonnie Cir
- City
- Corona
- State
- CA
- ZIP
- 92878
- 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 |
|---|---|---|---|---|---|
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2012-11-15 |
Proprietary Names
Irrigating Syringe
Flat top piston irrigation syringe 60cc ST
Enteral irrigation syringe 60cc NS
Piston enteral irrigation syringe 60cc NS
Thumb control piston irrigation syringe 60cc ST
IRRIGATION TRAY
Igloo Wound Irrigatior
Bulb irrigation syringe 60cc ST
RXP (Rapid Exchange Flushing Syringe
EAR BULB SYRINGE
Igloo Wound Irrigation System
Standard Trach Care Kit
Soft tray W/ Piston Syringe
ABSCESS CAP
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)