FDA Registration
Active
🇺🇸 United States
Dental Medical Devices
Reg #: 1061124
·
FEI: 1000512168
·
Expires 2025
Products
1
Proprietary Names
19
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S., LLC
- Registration Number
- 1061124
- FEI Number
- 1000512168
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10821 Withers Cove Park Dr
- City
- Charlotte
- State
- NC
- ZIP
- 28278
- 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 |
|---|---|---|---|---|---|
| Cotton, Roll | EFN | Class 1 | Dental | No | 2013-07-26 |
Proprietary Names
Dental Medical Devices
Richmond Dental & Medical
9920/50
L FZUSS 0160 R01201 US {USC STER USP ROLL 16 OZ/12}
9918/50
9915/50
L GLDL 0001 R01201 US {USC 454G CANADA COT ROLL 12/1}
9922/50
L FZUSS 0040 R02401 FBB {FIRST AID STER USP ROLL 4OZ/24}
9903/50
9902/50
9901/50
L FZUSS 0040 R02401 RT {RITE AID STER USP ROLL 4 OZ/24}
9905/50
9910/50
L FZUSS 0005 R07201 FBB {FIRST AID STER USP ROLL 1/2OZ}
9903/25
9911/50
9916/50
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)