FDA Registration
Active
🇺🇸 United States
BOTTOM HEADER WITH STRAIGHT CONNECTOR
Reg #: 2029275
·
FEI: 1000306431
·
Expires 2025
Products
1
Proprietary Names
16
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
Regulatory Submissions
- PMA Number
- P000036
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 |
|---|---|---|---|---|---|
| Dressing, Wound And Burn, Interactive | MGR | Class 3 | Unknown | No | 2012-10-30 |
Proprietary Names
BOTTOM HEADER WITH STRAIGHT CONNECTOR
TUBING ASSEMBLY, GROWTH FEED TREE, DG
TUBING ASSEMBLY, 12 MANIFOLD,
BIO-REACTOR ASSEMBLY
SIP MANIFOLD SET N/S
TUBING ASSY, 4 MANIFOLD, MEDIA GROWTH, DG
TUBING ASSEMBLY, INOC MEDIA TREE, DG
TUBING ASSY, SIP
TUBING ASSEMBLY, 12 MANIFOLD, CRYO, DG
TOP HEADER WITH 90 ø CONNECTOR
TUBING ASSY, 4 MANIFOLD, CRYO, DG
TUBING ASSY, INOCULATION TREE, DG
TUBING ASSY, 8 MANIFOLD, MEDIA GROWTH, DG
BIOREACTOR, APV, NO MESH
NO-MESH BAG ASSY, APV
TUBING ASSY, 8 MANIFOLD, CRYO, DG
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)