FDA Registration
Active
🇺🇸 United States
Instruments, Surgical, Cardiovascular NAMIC¿ Bottle/SOSA¿ Spike Clip
Reg #: 2011171
·
FEI: 2011171
·
Expires 2025
Products
1
Proprietary Names
17
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 |
|---|---|---|---|---|---|
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2012-11-19 |
Proprietary Names
Instruments, Surgical, Cardiovascular NAMIC¿ Bottle/SOSA¿ Spike Clip
NAMIC¿ Bottle/SOSA¿ Spike Clip
V-CATH INSERTION KIT
ONLY Sterile Handle sterilized
Assistant with StableSoft - 2L
AORTIC PUNCH (APU PRODUCT FAMILY)
Assistant with StableSoft - 2S
Assistant with StableSoft - 3L
Contamination Sleeve
Worely Slitter
Assistant with StableSoft 3S Flex
Assistant with StableSoft - 3S
Cutter
Transavalvular Insertion Tool (TVI)
Assistant with StableSoft 3L Flex
Polyester Tape
ELIZABETH
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)