FDA Registration
Active
🇨🇭 Switzerland
Integra LifeSciences Switzerland Sarl
Reg #: 3013886523
·
FEI: 3013886523
·
Expires 2026
Products
6
Proprietary Names
91
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Integra LifeSciences Switzerland Sarl
- Registration Number
- 3013886523
- FEI Number
- 3013886523
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Rue Girardet 29, Second Floor
- City
- Le Locle Neuchatel
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K053244
Owner / Operator
- Firm Name
- Integra LifeSciences Corporation
- Operator Number
- 9004007
- Address
- 1100 Campus Rd
- City
- Princeton
- State
- NJ
- Postal Code
- 08540
- Country
- US
US Agent
- Business Name
- Intgra LifeSciences Corporation
- Contact Name
- Kerri DiPietro
- Address
- 11 Cabot Blvd
- City
- Mansfield
- State
- MA
- ZIP
- 02048
- Country
- US
- [email protected]
- Phone
- 774 7196909
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Monitoring, Intracranial Pressure | GWM | Class 2 | Neurology | No | 2007-12-18 |
| Shunt, Central Nervous System And Components | JXG | Class 2 | Neurology | No | 2022-06-21 |
| Catheter, Ventricular | HCA | Class 2 | Neurology | No | 2024-03-13 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2000-12-14 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2017-09-26 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 1999-04-27 |
Proprietary Names
Licox IMC Complete Neuromonitoring
Licox IT2 Complete Brain Tunneling
CODMAN EDS 3 - CSF External Drainage System
Bactiseal Catheters
Bactiseal Barium Striped Catheters
Bactiseal Endoscopic Ventricular Catheter
Jarit
Miltex
Codman Instrument Tray
Integra
Integra Allograft Wedge Instrument Tray Assembly
OSVII Lumbar Valve System
OSVII Low Flow Lumbar Valve
CODMAN VPV SYSTEM, MODEL 82-3192
CODMAN® BACTISEAL® Ventricular Catheter and Distal Catheter Kit
External Drainage Set
Certas Plus Programmable Valve
CODMAN BACTISEAL EVD CATHETER SET
CODMAN Integrated Bipolar Cord And Tubing Set
CODMAN® BACTISEAL® Clear with Barium Stripe Catheter Kit
OSVII and OSV Low Pro Valve Systems
Hakim Percision Valve System
CODMAN® HAKIM® Precision Fixed Pressure Valve
CODMAN® HAKIM® Programmable Valve; CODMAN® MEDOS® Ventricular Catheter
Codman Certas Plus Programmable Valves
CereLink ICP Sensor
CODMAN EDS 3 - CSF External Drainage System no Catheter
CODMAN® ACCU-FLO® Straight Connector
CODMAN® HOLTER®
CODMAN HAKIM SHUNT SYSTEMS
Ruggles-Redmond
Codman Ventricular Needles
Subcutaneous Guidewire
Arkis Subcutaneous Guideware
Codman Certas Toll Kit
CODMAN CERTAS PLUS PROGRAMMAGLE VALVE SYSTEM
CODMAN® HAKIM® Valve Programmer
LICOX BRAIN OXYGEN MONITORING SYSTEM
CATHETER PROBES AND KIT
Integra Flow Regulating Valve
CODMAN® HAKIM® Programmable Valve
CODMAN MICROSENSOR Skull Bolt Kits
Codman Microsensor Metal Skull Bolt Kit
Codman Microsensor Ventricular Catheter Kit
Codman Microsensor Plastic Skull Bolt Kit
Codman Microsensor Ventricular Catheter Kit With Tuohyborst Adapter
Codman Microsensor Basic Kit
NPH Low Flow Valve
Codman Accessories Ventricular Kit
Codman Accessories Cables
Codman Accessories Drill Kit
Codman Accessories ICP Transducer Basic Kit
Codman Microsensor Intracranial Pressure Transducer and Accessories
Codman Microsensor
Codman Accessories Interface Control Unit Kit
Codman Accessories Cranial Access Kit
Codman Accessories Bolt Kit
Codman Accessories Neuro Monitor
Codman Bactiseal Endoscopic Ventricular Catheter
Codman Bactiseal Ventricular Catheter
Codman Hakim Programmable Valves
Codman Hakim Precision Fixed Pressure Valves
Alleghany CSF External Drainage Sys
Pudenz Catheters
Integra Reservoirs
Braden Reservoir
Pudenz Peritoneal Catheter
Mishler Valve Systems
Hermetic External CSF Drainage Syst
Pudenz Valves
On-Off Flushing Valves
Multi-Purpose Valves
External CSF Drainage Systems
Pudenz Cardiac Catheters
Codman External Drainage System II
CODMAN® HAKIM® Programmable Valve with SIPHONGUARD® Device
CODMAN® HAKIM® Precision Fixed Pressure Valve with SIPHONGUARD® Device
HAKIM PROGRAMMABLE VALVE SYSTEM
HAKIM MICRO PROGRAMMABLE VALVE SYSTEM
SiphonGuard TM CSF Control Device
HAKIM PRECISION VALVE SYSTEM
Bactiseal EVD Catheter Sets:
Bactiseal Clear EVD Catheter Set
CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps
CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps
DirectLink ICP Extension Cable
Patient Monitor Interface Cables
DirectLink ICP Module
CODMAN® BACTISEAL® Clear EVD Catheter
OSVII
Integra Flow Regulating Valve Low Flow
Establishment Types
Manufacture Medical Device