FDA Registration
Active
🇺🇸 United States
02.226.140S
Reg #: 2029275
·
FEI: 1000306431
·
Expires 2025
Products
1
Proprietary Names
90
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
- 510(k) Number
- K050636
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 |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-05-06 |
Proprietary Names
02.226.140S
02.226.120S
02.226.116S
04.226.118S
04.22619S
04.22640S
04.226.134S
02.22624S
02.22628S
02.22619S
04.226.129S
02.226.136S
04.22611S
02.22640S
04.226.126S
04.22621S
02.22629S
04.22616S
04.22632S
02.226.124S
04.22620S
02.226.117S
02.22621S
04.22618S
02.226.134S
02.22610S
04.226.123S
02.22613S
02.22622S
04.22623S
02.22620S
02.226.130S
04.22630S
02.226.122S
04.226.130S
04.226.119S
04.226.116S
04.22617S
02.226.121S
04.22626S
02.22630S
02.226.128S
02.226.129S
04.22612S
04.22613S
04.22628S
02.226.127S
02.226.125S
02.22612S
02.226.123S
04.22636S
04.22622S
04.22614S
02.22616S
02.226.119S
02.226.138S
02.22627S
02.22623S
04.226.122S
04.226.120S
04.226.121S
04.226.124S
02.226.132S
04.22638S
04.22625S
04.22634S
04.226.132S
02.22626S
04.226.128S
02.22638S
02.22632S
02.22625S
02.226.126S
04.226.117S
02.22634S
04.226.125S
04.22615S
02.22615S
04.22610S
04.22627S
04.226.127S
02.22636S
04.226.138S
04.22624S
02.22614S
04.226.136S
04.22629S
02.22617S
04.226.140S
02.226.118S
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)