FDA Registration
Active
🇺🇸 United States
4.7MM CANN HEXDRIVER SHAFT - 127MM
Reg #: 1526534
·
FEI: 1526534
·
Expires 2025
Products
1
Proprietary Names
33
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics US, LLC
- Registration Number
- 1526534
- FEI Number
- 1526534
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 305 Enterprise Dr
- City
- Lewis Center
- State
- OH
- ZIP
- 43035
- 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 |
|---|---|---|---|---|---|
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2012-11-01 |
Proprietary Names
4.7MM CANN HEXDRIVER SHAFT - 127MM
HEX T-DRIVER 1/2
T20 SELF-RET SCREWDRIVER W/QC 165MM
MEDTRONIC Facet Screw Instruments
TARGETER 4.7MM HEXDRIVER SHAFT
4.7MM HEXDRIVER
T15 REM SCREWDRIVER W/QC 178MM
3.5MM TGR HEXDRVER SHFT CANN
T25 SELF-RET SCREWDRIVER W/QC 203MM
T7 SCREWDRIVER W/QC 62MM
3.5MM S/R HEXDRIVER SH 119MM
T20 SELF-RET SCREWDRIVER W/QC 120MM
CANN T10 SCREWDRIVER SHAFT W/AO
2.5MM CANN HEXDRIVER SHAFT - 120MM
T20 REM SCREWDRIVER W/QC 178MM
4.7MM BALL HEXDRIVER
T25 SELF-RET SCREWDRIVER SHAFT 120MM
3.5MM HEXDRIVER SHAFT AO QC
3.5MM S/R HEXDRIVER SH 178MM
3.5MM CANNULATED HEXDRIVER
T15 SELF-RET SCREWDRIVER SHAFT 178MM
2.5MM HEXDRIVER SHAFT AO QC
T20 SELF-RET SCREWDRIVER SHAFT - 178MM
T15 SELF-RET SCREWDRIVER W/QC 120MM
HEX SCREWDRIVER SHAFT
4.7MM CANN HEXDRIVER SHORT
4.7MM HEXDRIVER SHAFT
3.5MM TGR SELF-RET HEX 203MM
LARGE FRAG SCREWDRIVER HANDLE
4.7MM HEXDRIVER SHAFT W/ QC
TGR 3.5MM LG FRAG CAN HEXDRV
Facet Screw Insruments
Medtronic Instrument
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)