FDA Registration
Active
🇺🇸 United States
HINGE JOINT
Reg #: 3002907620
·
FEI: 3002907620
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics US LLC
- Registration Number
- 3002907620
- FEI Number
- 3002907620
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1700 College Blvd.
- City
- West Memphis
- State
- AR
- ZIP
- 72301
- Country
- US
Regulatory Submissions
- 510(k) Number
- K970751
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 |
|---|---|---|---|---|---|
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2017-07-03 |
Proprietary Names
HINGE JOINT
ILIZAROV RING ADAPTOR
CARDAN JOINT
STANDARD CENTRAL BODY
SHORT CENTRAL BODY
ANGULATOR HEIDELBERG
Straight Clamp
HEIDELBERG T-CLAMP
PIN TOWER
CENTRAL PIN FIXATION UNIT
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)