FDA Registration
Active
🇺🇸 United States
STYLET
Reg #: 1721676
·
FEI: 1721676
·
Expires 2025
Products
1
Proprietary Names
4
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 |
|---|---|---|---|---|---|
| Catheter, Peritoneal | GBW | Class 1 | General, Plastic Surgery | No | 2014-07-08 |
Proprietary Names
STYLET
Peritoneoscopic or Laparoscopic Peritoneal Dialysis Catheter Implantation Systems
Laparoscopic Peritoneal Dialysis Catheter Implantation System
Percutaneous Peritoneal Dialysis Catheter Implantation Systems
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)