INTEGRA NEUROSCIENCES

Matched from indexed company URL: Integra Neurosciences

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
26489883000204775INTEGRA NEUROSCIENCES1N2026-01-01ROAD 402 NORTH, KM 1.2 ANASCO PR US 00610
96120073003813779Integra NeuroSciences Implants (France) S.A.S.1N2020-04-252905 ROUTE DES DOLINES Sophia Antipolis CEDEX Alpes-Maritimes FR 06921

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10381780034124Lumbar Catheter Accessory Kit - The Lumbar Catheter Accessory Kit (LCAK) is designed for cerebrospinal fluid drainage, and consists of: a 80 cm radiopaque lumbar catheter (F5) with graphite based length marks at 2 cm intervals (first mark at 10 cm from the closed tip); a guidewire in dispenser; a Luer-lock connector; a butterfly suture clamp; a 14-ga, thin-wall Tuohy needle with obturator.+1(800)654-2873custsvcnj@integralife.com
10381780034193Integral Drainage Set - The Integral Drainage Set (IDS) consists of a one-piece assembly (male Luer-lock connector; small diameter drainage inlet tube with attached clamp, check valve, and silicone band; graduated bag with hydrophobic vent filter, drip chamber, suspension string with adjustable clip; large diameter drainage collector; outlet tube with clamp, watertight cap and silicone band); a 360° three-way stopcock Luer-lock connectors; 35 cm radiopaque straight ventricular catheter.+1(800)654-2873custsvcnj@integralife.com
10381780034209Integral Drainage Set - The Integral Drainage Set (IDS) consists of a one-piece assembly (male Luer-lock connector; small diameter drainage inlet tube with attached clamp, check valve, and silicone band; graduated bag with hydrophobic vent filter, drip chamber, suspension string with adjustable clip; large diameter drainage collector; outlet tube with clamp, watertight cap and silicone band); a 360° three-way stopcock Luer-lock connectors; a lumbar catheter accessory kit+1(800)654-2873custsvcnj@integralife.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
129691773461133P850010HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGELMF1985-11-08
129691815776200P840062COLLACOTE(TM)LPG1985-11-08
129691115660182P810006COLLASTATLMF1981-12-10
129691804661727K992216BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANELYC1999-07-26
129691421461965K983603REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAMEHAW1998-11-10
129691604503948K982180DURAGEN DURAL GRAFT MATRIXGXQ1999-07-06
129691408053185K981262CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEMLFL1998-07-06
129661578640015K974726SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETERJXG1998-03-18
129691964117342K974708GEMINI STANDARD AND MINI VALVESJXG1998-03-10
129691238886251K973525MAURICE WORLDWIDE SHUNT SYSTEMJXG1997-12-16
129691027266655K972994EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMSJXG1997-11-03
129691608911441K971617ENDOSCOPIC VENTRICULAR CATHETERJXG1997-07-31
129691894235753K970983PERITONEAL/CARDIAC CATHETERJXG1997-06-13
129691297804740K970658LUMBAR DRAINAGE ACCESSORY KITJXG1997-05-19
129691389925282K964371SHUNT TAP WITH ICP MONITORING ACCESS PORTJXG1997-01-31
129691964666166K963802SHUNT TAPJXG1996-12-12
129691745465512K961859NOVUS STANDARD AND PEDIATRIC VALVESJXG1996-12-16
129661641649783K960159CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)JXG1996-10-25
129661909342503K955832CORDIS VENTRICULAR ANTECHAMBER (VA)JXG1996-03-25
129662056522732K955265CORDIS SHARP-ENDED STYLET; BLUNT-ENDED STYLET; CYST PUNCTURE CATHETERJXG1996-12-20
129661655835660K950315CORDIS CSF RESERVOIRLKG1995-05-09
129661018648418K944595CORDIS HORIZONTAL-VERICAL VALVE SYSTEMJXG1995-10-19
129661303141437K940648CORDIS DISPOSABLE ICP PRESSURE TRANSDUCERGWM1995-03-01
129691406943699K932769CAMINO VENTRICULAR DRAINAGE SYSTEMJXG1995-03-30
129661616226080K932429CORDIS GRAVITY COMPENSATING ACCESSORYJXG1994-07-20
129661036024056K932273CORDIS TUNNELERGYK1993-08-23
129661220316741K926424CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MONGYC1993-11-19
129661052394912K925810CORDIS POLYPROPYLENE BURR HOLE RESERVOIRJXG1994-03-02
129661513838800K924600INTEGRAL DRAINAGE/VENTRICULAR/LUMBAR DRAINAGE SETSJXG1992-12-10
129691068977830K924408COLLA-TEC ABSORBABLE COLLAGEN MEMBRANELYC1995-08-22
129661570454509K924226OJEMANN CORTICAL STIMULATORGYC1993-04-21
129661601632195K921936CORDIS POLYPROPYLENE STRAIGHT, T & Y CONNECTORJXG1992-10-30
129691584229564K920156CLINICAL NEURO SYST MONITORR EXT CSF DRAIN/MONI SYJXG1992-03-16
129661945714257K914995CORDIS STRAIGHT VENTRICULAR CATHETERJXG1992-03-09
129661996360496K913842CORDIS RIGHT-ANGLE CATHETER GUIDEJXG1992-02-19
129661238218485K911433RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGEJXG1991-09-16
129691710884806K895868HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSEGYK1989-10-31
129691814887643K894072THE PUDENZ IN LINE VALVEJXG1989-08-07
129691095963773K891456HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAMJXG1989-06-23
129691389852607K873771HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTROGYK1987-12-18
129691996034365K864676HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEMJXG1986-12-29
129661433315084K861377STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVESJXG1986-06-19
129661324875922K855058EVDS, EVMDS, LDS & IVMCS CENTRAL NERVOUS SYS FLUIDJXG1986-01-10
129661057024960K854657INTRACRANIAL PRESSURE MONITORING CUP CATHETERSGWM1985-12-27
129691904772670K854049HEYER-SCHULTE SYRINGO PERITONEAL SHUNTJXG1985-11-27
129692057061035K823790VENTRICULAR ACCESS SYSTEMLKG1983-04-28
129691160878605K820247EXTERNAL VENTRICULAR DRAINAGE SYS.JXG1982-02-18
129691014635216K811288SPETZLER LUMBAR-PERITONEAL SYSTEMJXG1981-06-26
129691926125002K802586AMERICAN HEYER-SCHULTE LOW PROFILE VALVEJXG1980-12-18
129661064178777K771529PERITONEAL INTRODUCER & SHEATHGYK1977-08-16
129692024408817K760785MISHLER 2 CHAMB FLUSHING VALVE,ANTI-SYPHJXG1976-11-01
129691398626056K760784MISHLER 2 CHAMB FLUSHING VALVE,STANDJXG1976-11-01
129691954289082K760502VALVE, ANTI-SYPHON MODEL PUDENZE FLUSH.JXG1976-08-30
129692020915121K760501VALVE, STANDARD MODEL PUDENZE FLUSHINGJXG1976-08-30
129691824474489K230427CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2023-07-11
129691746230866K221835CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2022-08-22
129691942806843K221763CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2022-07-15
129691850096439K191684MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage SystemJXG2019-10-11
129691670523884K190180CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2019-04-01
129691755722249K182809CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2018-12-07
129661345798448K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsJXG2016-09-22
129691345798448K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsJXG2016-09-22
129692016034898K161882CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL2016-10-14
129691201944691K153041Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional LabelingJXG2016-03-14
129661463597524K152897Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating AccessoryJXG2016-03-04
129691892720264K141674CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEMLFL2014-11-06
129661602032618K140722INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELSJXG2015-01-06
129692052951077K113570INTEGRA CUSA NXT INFERIOR FOWARD BONE TIPLFL2012-02-22
129691575045850K111741INTEGRA(TM) CUSA NXT(TM) BONE TIPSLFL2011-08-23
129691776535364K102258CUSA NXT EXTENDED LENGTH TIPLFL2011-06-10
129662062437439K101381HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMSJXG2011-07-07
129661196189534K093968OSV II LOW FLOW LOW PRO VALVEJXG2010-01-22
129661889763245K092395OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEMJXG2009-11-19
129691156881718K092388DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MOGXQ2010-01-21
129691948464912K091302INTEGRA MOZAIK AND OS MOLDABLE MORSELSMQV2009-12-04
129691737532453K090864CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEMLFL2009-05-08
129661680939872K082250AURAGEN CORTICAL SURFACE ELECTRODESGYC2008-10-10
129661653267825K081773OSV IIJXG2008-11-06
129691795204646K081459CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEMLFL2008-08-13
129691988002658K072929LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030JXG2007-12-07
129691058030068K072207DURAGEN XS DURAL REGENERATION MATRIXGXQ2007-08-23
129691886777497K071669INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIPLFL2007-08-17
129691087135514K062599MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMSJXG2006-09-27
129661523342892K053244LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KITGWM2006-05-10
129692026484921K051947RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONELFL2005-08-22
129691922260101K043427DURAGEN II DURAL REGENERATION MATRIXGXQ2005-01-12
129691808555202K042825ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEMJXG2004-12-21
129661582350957K042558EQUI-FLOW VALVE AND SHUNT SYSTEMJXG2004-10-06
129661575710423K042192LOW FLOW OSV II HYDROCEPHALUS VALVEJXG2004-09-02
129692020203644K041620NEURA WRAP NERVE PROTECTORJXI2004-07-16
129661344293041K040235LICOX PMO BRAIN MONITORING SYSTEMGWM2004-04-20
129661710426978K033698CONTOUR-FLEX VALVE AND SHUNT SYSTEMJXG2003-12-17
129661188378649K032817EXTERNAL DRAINAGE SETJXG2003-10-06
129691188378649K032817EXTERNAL DRAINAGE SETJXG2003-10-06
129691353387804K032693DURAGEN PLUS DURAL GRAFT MATRIXGXQ2003-09-30
129691384582507K030289HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830NJXG2003-02-26
129691391792932K022554MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEMJXG2002-08-23
129691277946391K021989SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3LFL2002-09-13
129691159662740K011168NEUROGEN NERVE GUIDEJXI2001-06-22
129691419770286K003229BIOPATCH ANTIMICROBIAL DRESSINGSEL2001-10-26
129661595200704K002765LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPEGWM2000-11-24
129661221810373
129661271125503
129661301371333
129661316585240
129691773769341
129661940505182
129691029764925
129691159013706
129691333595682
129691385218818
129691786446524

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JXG562019-10-11
LFL162023-07-11
GXQ52010-01-21
GWM52006-05-10
GYK41993-08-23
GYC32008-10-10
JXI22004-07-16
LYC21999-07-26
LKG21995-05-09
LMF21985-11-08
MQV12009-12-04
SEL12001-10-26
HAW11998-11-10
LPG11985-11-08

PMN#

GUDID#

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