FDA Registration
Active
🇫🇷 France
Right Angle Ventricular Catheter 7 cm
Reg #: 3007156625
·
FEI: 3008133910
·
Expires 2025
Products
1
Proprietary Names
45
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
- K013488
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
Right Angle Ventricular Catheter 7 cm
Paediatric Straight Ventricular Catheter 1.3 x 2.2
Right Angle Ventricular Catheter Reservoir 8 cm
Right Angle Ventricular Catheter Res. / Pectoral 8 cm
Standard Straight Ventricular Catheter 1.3 x 2.5
Convertible CSF Reservoir, Flat Bottom Large Model / Catheter
Right Angle Ventricular Catheter Reservoir 6 cm
Right Angle Ventricular Catheter Reservoir 9 cm
Right Angle Ventricular Catheter 9 cm
Right Angle Ventricular Catheter 6 cm
Right Angle Ventricular Catheter Reservoir 7 cm
Right Angle Ventricular Catheter Res. / Pectoral 10 cm
Right Angle Ventricular Catheter 8 cm
Standard CSF Reservoir, Burr Hole Large Model / Catheter
Right Angle Ventricular Catheter Res. / Pectoral 11 cm
Right Angle Ventricular Catheter Reservoir 5 cm
Convertible CSF Reservoir, Burr Hole Large Model / Catheter
Right Angle Ventricular Catheter Res. / Pectoral 7 cm
Anti-reflux Atrial Catheter
Right Angle Ventricular Catheter Reservoir 4 cm
In-line CSF Reservoir , Double Dome / Catheter
Standard CSF Reservoir, Flat Bottom Large Model / Catheter
Titanium Asymmetrical Connector
Side-Inlet CSF Reservoir, Flat Bottom Small Model / Catheter
Right Angle Ventricular Catheter Res. / Pectoral 6 cm
Right Angle Ventricular Catheter 5 cm
Right Angle Ventricular Catheter Reservoir 3 cm
Convertible CSF Reservoir, Flat Bottom Small Model / Catheter
Side-Inlet CSF Reservoir, Flat Bottom Large Model / Catheter
Right Angle Ventricular Catheter Res. / Pectoral 9 cm
Peritoneal Catheter
Straight Ventricular Catheter 1.5 x 3
Graduated Straight Ventricular Catheter 1.3 x 2.2
Right Angle Ventricular Catheter Res. / Pectoral 3 cm
Right Angle Ventricular Catheter Res. / Pectoral 12 cm
Polypropylene 3-way Connector
Convertible CSF Reservoir, Burr Hole Small Model / Catheter
Right Angle Ventricular Catheter Reservoir 12 cm
Right Angle Ventricular Catheter Res. / Pectoral 5 cm
Right Angle Ventricular Catheter Reservoir 11 cm
Anti-reflux Peritoneal Catheter
In-line CSF Reservoir , Single Dome / Catheter
Right Angle Ventricular Catheter 4 cm
Right Angle Ventricular Catheter Res. / Pectoral 4 cm
Titanium Symmetrical Connector
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)