FDA Registration
Active
🇺🇸 United States
Insufflation Set
Reg #: 1721676
·
FEI: 1721676
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S., LLC
- Registration Number
- 1721676
- FEI Number
- 1721676
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5725 Harold Gatty Dr
- City
- Salt Lake City
- State
- UT
- ZIP
- 84116
- 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 |
|---|---|---|---|---|---|
| Bulb, Inflation, For Endoscope | FCY | Class 1 | Gastroenterology, Urology | No | 2012-11-09 |
Proprietary Names
Insufflation Set
KI527/50
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)