FDA Registration
Active
🇺🇸 United States
Biopsy Needles
Reg #: 3004111573
·
FEI: 3004111573
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics US LLC
- Registration Number
- 3004111573
- FEI Number
- 3004111573
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1302 Avenue T
- City
- Grand Prairie
- State
- TX
- ZIP
- 75050
- 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 |
|---|---|---|---|---|---|
| Needle, Biopsy, Cardiovascular | DWO | Class 1 | General, Plastic Surgery | No | 2012-12-19 |
Proprietary Names
Biopsy Needles
M-Biopsy Needle For Reusable Biopsy Instruments
Bone Marrow Biopsy and Aspiration Needles Double Diamond "J" and "I" Type Bone Marrow Needle
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)