FDA Registration
Active
🇫🇷 France
Pediatric Right Angle ventricular catheter, Vision, 9 cm
Reg #: 3007156625
·
FEI: 3008133910
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics SAS
- Registration Number
- 3007156625
- FEI Number
- 3008133910
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8 Rue Parmentier
- City
- Rantigny Oise
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K853371
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 |
|---|---|---|---|---|---|
| Shunt, Central Nervous System And Components | JXG | Class 2 | Neurology | No | 2020-01-27 |
Proprietary Names
Pediatric Right Angle ventricular catheter, Vision, 9 cm
6 " Open End Catheter
Open-Pliant Peritoneal Catheter
Closed-Pliant Peritoneal Catheter, 90 cm
Pediatric Right Angle ventricular catheter, Vision, 7 cm
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)