FDA Registration
Active
🇺🇸 United States
CS-600.1
Reg #: 1423662
·
FEI: 3000215273
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics US LLC
- Registration Number
- 1423662
- FEI Number
- 3000215273
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1003 Lakeside Drive
- City
- Gurnee
- State
- IL
- ZIP
- 60031
- 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 |
|---|---|---|---|---|---|
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2012-11-13 |
Proprietary Names
CS-600.1
CS-490.1
Sepax kit CS-xxx.x and accessories AK-xxx, FA-xxx.x ; CryoSC cryobag FB-xxx.x
CS-900.X
ART BMC Plus
ART BMC
CS-900.2
Centrifuge & accessorices for blood/bone marrow aspirate sequestration
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)