Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006697299

FEI Number

3006697299

Entity Name

INTEGRA LIFESCIENCES (IRELAND) LIMITED

City/State/Country

SRAGH TULLAMORE Offaly, IE

Establishment Address

IDA BUSINESS and TECHNOLOGY PARK, SRAGH TULLAMORE Offaly --, IE

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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CUSA EXCEL Ultrasonic Surgical Aspirator System Integra Luxtec UltraLitePro UltraLite Plus Integra Flexible EEG Cable Flexible EEG Cables CUSA Clarity Ultrasonic Surgical Aspirator System; C7023; C7123; C7623; C7601; C7601EA CODMAN CERTAS Plus Electronic Tool Kit CUSA Clarity Ultrasonic Surgical Aspirator System; C7602; C7602EA Miltex Padgett Integra Luxtec DLX UltraLite Pro MicroFrance Luxtec Fiber Optic Cables Integra Acclarent Light Guide Cable Adapters Relieva Luma Light Guide Cable 2 Integra Licox Pt02 Monitor Accessories Micro Ventricular Bolt Pressure/Temperature Monitoring Kit Single Parameter Monitor SPM-1 CUSA Excel+ Ultrasonic Surgical Aspirator System; C2623; C5623; CUSAEXCEL2; C2600; C5601; C5602 CUSA Clarity 23kHz CEM Nosecone Integra® Duo LED Surgical Headlight System CUSA® Clarity 23 kHz Expanded CEM Nosecone CUSA® Clarity 23 kHz Standard Laparoscopic Tip CUSA® Clarity 23 kHz Extended Laparoscopic Tip Integra LICOX PT02 Monitor Integra Luxtec DLX UltraLite Pro Camera System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LBK	Neurosurgical Ultrasonic Instruments	Unknown	Class U	N/A	2005-10-03
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2005-10-03
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2007-12-04
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2003-07-15
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2019-01-03
LBK	Neurosurgical Ultrasonic Instruments	Unknown	Class U	N/A	2019-01-03
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2019-11-01
LBK	Neurosurgical Ultrasonic Instruments	Unknown	Class U	N/A	2016-10-21
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2016-10-21
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2003-07-25
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2012-10-25
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2008-01-08
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2008-02-28
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2015-02-20
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2019-04-26
LBK	Neurosurgical Ultrasonic Instruments	Unknown	Class U	N/A	2019-04-26
FSR	Light, Headband, Surgical	Ophthalmic	Class 2	886.4335	2018-08-28
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-07-12
LBK	Neurosurgical Ultrasonic Instruments	Unknown	Class U	N/A	2023-07-12
LBK	Neurosurgical Ultrasonic Instruments	Unknown	Class U	N/A	2022-08-18
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2022-08-18
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2013-10-21
FWC	Camera, Television, Surgical, With Audio	General, Plastic Surgery	Class 1	878.4160	2003-07-16

Official Correspondent

No official correspondent registered.

US Agent Details

Kerri DiPietro Business: Integra 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
2648988	INTEGRA NEUROSCIENCES	ANASCO, PR, US
9680837	INTEGRA MICROFRANCE SAS	SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FR
3004608878	INTEGRA LIFESCIENCES CORPORATION	CINCINNATI, OH, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K071458	Integra LifeSciences Corporation	MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS	2007-06-13
K901491	Cuda Products Co.	CUDA SURGICAL LIGHT	1990-06-18
K981246	Integra Neurocare, LLC	BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)	1999-05-26
K020558	Integra Neurosciences	LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE	2002-03-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0332-2022	Covidien Llc	U	Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA

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3004608878	INTEGRA LIFESCIENCES CORPORATION	CINCINNATI, OH, US
1319639	Sterigenics U.S., LLC	Queensbury, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006697299. Last updated year: 2026. Please use registration number 3006697299 when referencing this establishment in official correspondence.