FDA Registration
Active
🇺🇸 United States
Endoscope and accessories ELECTRODE, PK PLASMA-SECT (LOOP)
Reg #: 3004111573
·
FEI: 3004111573
·
Expires 2025
Products
4
Proprietary Names
2
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Sterigenics US LLC
- Registration Number
- 3004111573
- FEI Number
- 3004111573
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1302 Avenue T
- City
- Grand Prairie
- State
- TX
- ZIP
- 75050
- Country
- US
Regulatory Submissions
- 510(k) Number
- K001270
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 |
|---|---|---|---|---|---|
| Resectoscope | FJL | Class 2 | Gastroenterology, Urology | No | 2012-12-03 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2012-12-03 |
| Electrode, Electrosurgical, Active, Urological | FAS | Class 2 | Gastroenterology, Urology | No | 2012-12-03 |
| Resectoscope, Working Element | FDC | Class 2 | Gastroenterology, Urology | No | 2012-12-03 |
Proprietary Names
Endoscope and accessories ELECTRODE, PK PLASMA-SECT (LOOP)
Endoscope and accessories ELECTRODE, PK PLASMA-SECT (4 mm LOOP)
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)