Integra LifeSciences Switzerland Sarl

FDA Device Registration & Listing · Le Locle Neuchatel, CH · Registration 3013886523

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013886523
FEI Number
3013886523
Entity Name
Integra LifeSciences Switzerland Sarl
City/State/Country
Le Locle Neuchatel, CH
Establishment Address
Rue Girardet 29, Second Floor, Le Locle Neuchatel Ch-2400, CH
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Integra LifeSciences Corporation (Owner Number: 9004007)
Owner / Operator Contact Address
1100 Campus Rd, Princeton, NJ 08540, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 EDS 3 - CSF External Drainage System 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® 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 Integra Jarit 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 LICOX BRAIN OXYGEN MONITORING SYSTEM CATHETER PROBES AND 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 CERTAS PLUS PROGRAMMAGLE VALVE SYSTEM CODMAN® HAKIM® Precision Fixed Pressure Valve CODMAN® HAKIM® Programmable Valve 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2007-12-18
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2022-06-21
HCA Catheter, Ventricular Neurology Class 2 882.4100 2024-03-13
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2024-03-13
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2000-12-14
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2010-01-22
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-18
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2019-12-05
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-09-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
HCA Catheter, Ventricular Neurology Class 2 882.4100 2017-09-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2014-09-22
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2023-02-13
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2020-01-28
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 1999-04-27
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2007-02-22
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2010-10-21
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2017-09-26
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2017-09-26
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2007-02-22
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-18
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2017-09-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2017-09-26
HCA Catheter, Ventricular Neurology Class 2 882.4100 2020-05-01
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2022-10-31
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2007-12-12

Official Correspondent

No official correspondent registered.

US Agent Details

Kerri DiPietro Business: Intgra LifeSciences Corporation Email: kerri.dipietro@integralife.com Phone: (774) 7196909

Related Public Records

Same Entity

Integra LifeSciences Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3015194982 SURGICAL INNOVATION ASSOCIATES, INC. Chicago, IL, US
3013505638 REBOUND THERAPEUTICS, CORPORATION Irvine, CA, US
3006697299 INTEGRA LIFESCIENCES (IRELAND) LIMITED SRAGH TULLAMORE Offaly, IE
2648988 INTEGRA NEUROSCIENCES ANASCO, PR, US
9680837 INTEGRA MICROFRANCE SAS SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K071458 Integra LifeSciences Corporation MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS 2007-06-13
K020558 Integra Neurosciences LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE 2002-03-21
K981246 Integra Neurocare, LLC BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730) 1999-05-26
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013886523. Last updated year: 2026. Please use registration number 3013886523 when referencing this establishment in official correspondence.
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