FDA Registration
Active
🇬🇧 United Kingdom
0606-515-000
Reg #: 3015219237
·
FEI: 3015219237
·
Expires 2025
Products
1
Proprietary Names
65
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STERIGENICS UK LIMITED
- Registration Number
- 3015219237
- FEI Number
- 3015219237
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Plot 13a, Seymour Link Road
- City
- Markham Vale Derbyshire
- Country
- GB
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 |
|---|---|---|---|---|---|
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2012-10-29 |
Proprietary Names
0606-515-000
0506-686-015
0606-520-000
0606-509-000
0306-563-000
0506-483-000
0506-689-015
General Surgical Instrument
KYPHON® Mixer
MIXOR FEMORAL PRESSURIZER-LG
VORTEX&MIXOR NZLE LONG TAPERED
VORTEX & MIXOR NOZZLE ANGLED
VORTEX&MIXOR NZLE STAND BRKAWY
VORTEX ADAPTER
ER2 Saturate Mixing System
VORTEX VACUUM BOWL
VORTEX VACUUM MIXING SYSTEM
VORTEX & MIXOR NOZZLE REVISION
VORTEX & MIXOR NOZZLE UMBRELLA
0206-556-000
0206-545-000
VORTEX RE-USE KIT
VACUUM TUBE W/SUC BYPASS
0206-546-000
0206-547-000
0206-548-000
0206-566-000
0206-509-000;0206-564-000
0506-683-015
0506-682-015
0606-514-000
0606-593-000S1
0605-687-015
0605-887-000
0506-482-000
Medium Port MiniMix Bone Cement Mixing System SMMM1
Mixing Bowl, Spatula B710
0606-595-000
0606-593-000
0606-563-000
0506-489-000
0606-553-000S1
0606-705-000S1
0606-516-000
0506-486-000
0606-517-000
RALLY Vacuum Mixing Bowl 7127-1801
0606-705-000
0606-573-000
0606-583-000
0605-683-015
0506-485-000
Kyphon Mixer
0306-564-000
0606-565-000
0605-685-015
0306-573-000
0506-687-015
0506-685-015
0606-512-000
HiVac Bowl Bone Cement Mixing System B713
0606-518-000
0606-553-000
MiniMix LV Bone Cement Mixing System SMLV
0306-553-000S2
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)