FDA Registration
Active
🇺🇸 United States
HALF PIN 6MM X 20MM
Reg #: 3002907620
·
FEI: 3002907620
·
Expires 2025
Products
1
Proprietary Names
35
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
- K953397
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 |
|---|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2017-07-03 |
Proprietary Names
HALF PIN 6MM X 20MM
DOUBLE PIN CLAMP
HALF PIN 6MM X 85MM
HALF PIN 6MM X 75MM
HALF PIN 6MM X 65MM
SS HALF PIN 6MM x 65MM
STAINLESS STEEL HALF PIN 6MM X 35MM
SS HALF PIN 6MM X 85MM
SINGLE SWIVEL CLAMP
SS HALF PIN 6MM X 20MM
STAINLESS STEEL HALF PIN 6MM X 25MM
Z-BAR
ADD A SWIVEL
TITANIUM HALF PIN 6MM X 45MM
SS HALF PIN 6MM X 45MM
Pelvic Ball Clamp
UNIVERSAL RING ADAPTER
HALF PIN 6MM X 30MM
CENTERING SLEEVE 5MM
DOUBLE SWIVEL CLAMP
SS HALF PIN 6MM x 75MM
COMP EX SHT HEX BAR-203MM
UNIVERSAL SWIVEL CLAMP
HEX BAR HEXFIX EX SHT 203MM AL
SINGLE PIN CLAMP
SS HALF PIN 6MM X 55MM
DRIVE UNIT
HALF PIN 6MM X 35MM
SS HALF PIN 6MM X 30MM
HALF PIN 6MM X 25MM
RING ADAPTER
TITANIUM HALF PIN 6MM X 55MM
CENTERING SLEEVE 6MM
HYBRID STRUT
BAR CONNECTOR
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)