FDA Registration
Active
🇺🇸 United States
NATURA Drainable and Urostomy Post-Op Kits, Ileostomy and Urostomy, Gentle Touch System or Kit-colostomy
Reg #: 1058584
·
FEI: 1000219637
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics US LLC
- Registration Number
- 1058584
- FEI Number
- 1000219637
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10811 Withers Cove Park Drive
- City
- Charlotte
- State
- NC
- ZIP
- 28278
- 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 |
|---|---|---|---|---|---|
| Bag, Drainage, With Adhesive, Ostomy | FON | Class 1 | Gastroenterology, Urology | No | 2013-06-28 |
Proprietary Names
NATURA Drainable and Urostomy Post-Op Kits, Ileostomy and Urostomy, Gentle Touch System or Kit-colostomy
NATURA BILAM UROACUCTFPOKIT57MM5STERUS
NATURA BILAMUROACUCTFPOKIT70MM5STERUS
EST+ S/HESIVEINVISIPOKIT100MM1X5STER EUR
ESTEEM+S/HESIVEINVISIPOKIT100MM1X5STERUS
NATURA BILAMUROACUCTFPOKIT45MMSTERUS
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)