FDA Registration
Active
🇺🇸 United States
Dover 100% Silicone Foley Catheter
Reg #: 2029015
·
FEI: 1000160458
·
Expires 2025
Products
1
Proprietary Names
21
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics U.S., LLC
- Registration Number
- 2029015
- FEI Number
- 1000160458
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 687 S Wanamaker Ave
- City
- Ontario
- State
- CA
- ZIP
- 91761
- 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 |
|---|---|---|---|---|---|
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FCM | Class 2 | Gastroenterology, Urology | No | 2017-07-07 |
Proprietary Names
Dover 100% Silicone Foley Catheter
Ultramer U/M Foley Tray: 8944MF
Ultramer U/M Foley Tray: 8944
Urine Meter: 2004
Ultramer U/M Foley Tray: 2014
Ultramer U/M Foley Tray: 2018
Ultramer U/M Foley Tray: 8950MF
Urine Meter: 2004LL
Urine Meter: 2006
Urine Meter: 2000
Ultramer U/M Foley Tray: 2016
Urine Meter: 2008
Urine Meter: 8101LL
Urine Meter: 8101
Urine Meter: 8000
Ultramer U/M Foley Tray: 6162
Ultramer U/M Foley Tray: 7008IC8942MF
Ultramer U/M Foley Tray: 2020
Ultramer U/M Foley Tray: 6165C
Ultramer U/M Foley Tray: 7006IC
Urine Meter: 8122
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)