FDA Registration
Active
🇺🇸 United States
ELEFANT
Reg #: 1036836
·
FEI: 1036836
·
Expires 2025
Products
1
Proprietary Names
49
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S., LLC
- Registration Number
- 1036836
- FEI Number
- 1036836
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1148 Porter Ave
- City
- Haw River
- State
- NC
- ZIP
- 27258
- 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 |
|---|---|---|---|---|---|
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2012-10-31 |
Proprietary Names
ELEFANT
Bio Med wash
POWERPLSE HIP/KNEE DISP UNT W/O SUC
0210-114-100S1
0210-212-000
POWERPULSE HIP/KNEE DISP UNT W/SUCT
0210-114-000S5
0210-114-000
0210-100-000
0210-016-000
0210-100-000S4
0210-918-000
0211-100-000
0210-010-100
0211-212-000
0210-018-000
0210-900-000
0210-010-100S1
0210-210-000
0210-118-100
0210-214-000
0210-918-100
0210-014-100
0211-112-000
0211-110-000
0210-118-000
0210-112-000
0210-018-200
0210-110-000
0211-214-000
0210-018-100
0210-166-000
0210-118-200
0210-058-000
0210-218-000
0210-014-000
0210-010-000
0210-200-000
0210-012-000
0210-167-000
0211-114-000
0210-114-100
0210-110-100
0210-158-000
0210-015-000
0211-118-000
0210-165-000
0210-218-100
0210-014-600
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)