FDA Registration
Active
🇺🇸 United States
DISPOSABLE DRILL TIP
Reg #: 2011171
·
FEI: 2011171
·
Expires 2025
Products
1
Proprietary Names
41
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics US LLC
- Registration Number
- 2011171
- FEI Number
- 2011171
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4900 Gifford Ave
- City
- Los Angeles
- State
- CA
- ZIP
- 90058
- 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 |
|---|---|---|---|---|---|
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2012-11-01 |
Proprietary Names
DISPOSABLE DRILL TIP
Kypho Pak Tray
NanoTack Drill Bit
Trinica
DRILL BITS
Access Tool, Cannulated Drill
Accesory Porta Kit
Parallax T-Grip Access Needle KP-TGN-1101-02
NanoTack Flex Drill Bit
VertecoR Bone Drill 3
CinchLock Drill Bit
SpineDriver 2mm bits
OVERDRILL FOR 2.4MM SCREWS W/ AO QC
2MM DRILL LONG W/AO QC
JETX 4.8 SHT GRAD STEP DRILL
1.5MM DRILL LONG WITH AO QC
OVERDRILL FOR 2.7MM SCREWS W/AO QC
Quattro Drills
VLP MINI-MOD 1.5MM OVERDRILL MINI QC
BioWick Drill Kits
MEDTRONIC Facet Screw Instruments
OVERDRILL FOR 2MM SCREWS W/AO QC
SureLock Drills
1.8MM DRILL LONG W/AO QC
1.8MM DRILL SHORT W/AO QC
2MM DRILL SHORT W/AO QC
ToggleLoc System
ACL Disposable Kit
Accessory Portal Kit
Quattro Bolt Accessory Drill Kits
Facet Screw Insruments
SIGMA HP TROCHLEA CUTTING BIT
14" Guidewire
3910-075-502;3910-075-652;3910-075-802;3910-090-502;3910-090-652;3910-090-802;0234-020-175
Flow-Drill
Comprehensive Augmented Glenoid Components
Comprehensive Mini Baseplate
Comprehensive Standard Baseplate
TOGGLELOC PUSHER
CAT02974
CAT02644
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)