FDA Registration
Active
🇺🇸 United States
329.632S
Reg #: 2953359
·
FEI: 3000215205
·
Expires 2025
Products
1
Proprietary Names
16
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S. LLC
- Registration Number
- 2953359
- FEI Number
- 3000215205
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2311 Lincoln Ave
- City
- Hayward
- State
- CA
- ZIP
- 94545
- 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 |
|---|---|---|---|---|---|
| Template | HWT | Class 1 | Orthopedic | No | 2013-07-17 |
Proprietary Names
329.632S
329.633S
329.634S
35113S
351.27S
35986S
3601S
PLASTIC TEMPLATE FOR CATHETER PLACEMENT
HIGH STRENGTH GUIDE PIN, 12 IN, STERILE, 2.4 X 305MM (93 X 12IN)
HIGH STRENGTH GUIDE PIN, 14 IN, STERILE, 2.4 X 356MM (93 X 14IN)
GRAFT PASSING GUIDE PIN, STERILE, 2.4 X 432MM (93 X 17IN)
GLOBAL AP REVISION TRL INSERT
LCS PAT PLAN REP BASK STD/STD+
GLOBAL AP BALL CYLIN TRL ASSEM
MISHA Knee System Targeting Kit
MISHA Knee System Trial
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)