OSV II
INTEGRA NEUROSCIENCES IMPLANTS S.A.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2648988 | 3000204775 | INTEGRA NEUROSCIENCES | 1 | N | 2026-01-01 | ROAD 402 NORTH, KM 1.2 ANASCO PR US 00610 |
| 9612007 | 3003813779 | Integra NeuroSciences Implants (France) S.A.S. | 1 | N | 2020-04-25 | 2905 ROUTE DES DOLINES Sophia Antipolis CEDEX Alpes-Maritimes FR 06921 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10381780035602 | Integral 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 with Luer-lock connectors; two stopcock protection boxes. | +1(800)654-2873 | custsvcnj@integralife.com |
| 10381780037248 | Straight Ventricular Catheter - The Integra NeuroSciences Ventricular Catheter is a 25 cm silicone elastomer tubing with full barium impregnation. Numbered length markers are located 5 and 10 cm from the proximal end. Length marker dots are located at 1 cm increments 3 to 14 cm from the proximal end. The proximal end presents fourty (40) flow holes. The proximal tip is constructed of molded, barium sulfate impregnated silicone to provide smooth, consistent end, which aid catheter placement. A stainless steel stylet and a right angle guide are provided. | +1(800)654-2873 | custsvcnj@integralife.com |
| M272ECCF61 | Integra® - The female electrode connecting cable is a reusable device used to connect the Integra® Cortical and Depth electrodes to an EEG monitor through a Cam Lock cylindrical Connector. It has 6 gold plated connector pins corresponding to the electrode Contacts, to be plugged into the corresponding EEG Monitor input channels. | +1(800)654-2873 | custsvcnj@integralife.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 12969 | 1773461133 | P850010 | HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE | LMF | 1985-11-08 |
| 12969 | 1815776200 | P840062 | COLLACOTE(TM) | LPG | 1985-11-08 |
| 12969 | 1115660182 | P810006 | COLLASTAT | LMF | 1981-12-10 |
| 12969 | 1804661727 | K992216 | BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE | LYC | 1999-07-26 |
| 12969 | 1421461965 | K983603 | REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME | HAW | 1998-11-10 |
| 12969 | 1604503948 | K982180 | DURAGEN DURAL GRAFT MATRIX | GXQ | 1999-07-06 |
| 12969 | 1408053185 | K981262 | CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM | LFL | 1998-07-06 |
| 12966 | 1578640015 | K974726 | SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER | JXG | 1998-03-18 |
| 12969 | 1964117342 | K974708 | GEMINI STANDARD AND MINI VALVES | JXG | 1998-03-10 |
| 12969 | 1238886251 | K973525 | MAURICE WORLDWIDE SHUNT SYSTEM | JXG | 1997-12-16 |
| 12969 | 1027266655 | K972994 | EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS | JXG | 1997-11-03 |
| 12969 | 1608911441 | K971617 | ENDOSCOPIC VENTRICULAR CATHETER | JXG | 1997-07-31 |
| 12969 | 1894235753 | K970983 | PERITONEAL/CARDIAC CATHETER | JXG | 1997-06-13 |
| 12969 | 1297804740 | K970658 | LUMBAR DRAINAGE ACCESSORY KIT | JXG | 1997-05-19 |
| 12969 | 1389925282 | K964371 | SHUNT TAP WITH ICP MONITORING ACCESS PORT | JXG | 1997-01-31 |
| 12969 | 1964666166 | K963802 | SHUNT TAP | JXG | 1996-12-12 |
| 12969 | 1745465512 | K961859 | NOVUS STANDARD AND PEDIATRIC VALVES | JXG | 1996-12-16 |
| 12966 | 1641649783 | K960159 | CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS) | JXG | 1996-10-25 |
| 12966 | 1909342503 | K955832 | CORDIS VENTRICULAR ANTECHAMBER (VA) | JXG | 1996-03-25 |
| 12966 | 2056522732 | K955265 | CORDIS SHARP-ENDED STYLET; BLUNT-ENDED STYLET; CYST PUNCTURE CATHETER | JXG | 1996-12-20 |
| 12966 | 1655835660 | K950315 | CORDIS CSF RESERVOIR | LKG | 1995-05-09 |
| 12966 | 1018648418 | K944595 | CORDIS HORIZONTAL-VERICAL VALVE SYSTEM | JXG | 1995-10-19 |
| 12966 | 1303141437 | K940648 | CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER | GWM | 1995-03-01 |
| 12969 | 1406943699 | K932769 | CAMINO VENTRICULAR DRAINAGE SYSTEM | JXG | 1995-03-30 |
| 12966 | 1616226080 | K932429 | CORDIS GRAVITY COMPENSATING ACCESSORY | JXG | 1994-07-20 |
| 12966 | 1036024056 | K932273 | CORDIS TUNNELER | GYK | 1993-08-23 |
| 12966 | 1220316741 | K926424 | CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON | GYC | 1993-11-19 |
| 12966 | 1052394912 | K925810 | CORDIS POLYPROPYLENE BURR HOLE RESERVOIR | JXG | 1994-03-02 |
| 12966 | 1513838800 | K924600 | INTEGRAL DRAINAGE/VENTRICULAR/LUMBAR DRAINAGE SETS | JXG | 1992-12-10 |
| 12969 | 1068977830 | K924408 | COLLA-TEC ABSORBABLE COLLAGEN MEMBRANE | LYC | 1995-08-22 |
| 12966 | 1570454509 | K924226 | OJEMANN CORTICAL STIMULATOR | GYC | 1993-04-21 |
| 12966 | 1601632195 | K921936 | CORDIS POLYPROPYLENE STRAIGHT, T & Y CONNECTOR | JXG | 1992-10-30 |
| 12969 | 1584229564 | K920156 | CLINICAL NEURO SYST MONITORR EXT CSF DRAIN/MONI SY | JXG | 1992-03-16 |
| 12966 | 1945714257 | K914995 | CORDIS STRAIGHT VENTRICULAR CATHETER | JXG | 1992-03-09 |
| 12966 | 1996360496 | K913842 | CORDIS RIGHT-ANGLE CATHETER GUIDE | JXG | 1992-02-19 |
| 12966 | 1238218485 | K911433 | RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGE | JXG | 1991-09-16 |
| 12969 | 1710884806 | K895868 | HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE | GYK | 1989-10-31 |
| 12969 | 1814887643 | K894072 | THE PUDENZ IN LINE VALVE | JXG | 1989-08-07 |
| 12969 | 1095963773 | K891456 | HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM | JXG | 1989-06-23 |
| 12969 | 1389852607 | K873771 | HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO | GYK | 1987-12-18 |
| 12969 | 1996034365 | K864676 | HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM | JXG | 1986-12-29 |
| 12966 | 1433315084 | K861377 | STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES | JXG | 1986-06-19 |
| 12966 | 1324875922 | K855058 | EVDS, EVMDS, LDS & IVMCS CENTRAL NERVOUS SYS FLUID | JXG | 1986-01-10 |
| 12966 | 1057024960 | K854657 | INTRACRANIAL PRESSURE MONITORING CUP CATHETERS | GWM | 1985-12-27 |
| 12969 | 1904772670 | K854049 | HEYER-SCHULTE SYRINGO PERITONEAL SHUNT | JXG | 1985-11-27 |
| 12969 | 2057061035 | K823790 | VENTRICULAR ACCESS SYSTEM | LKG | 1983-04-28 |
| 12969 | 1160878605 | K820247 | EXTERNAL VENTRICULAR DRAINAGE SYS. | JXG | 1982-02-18 |
| 12969 | 1014635216 | K811288 | SPETZLER LUMBAR-PERITONEAL SYSTEM | JXG | 1981-06-26 |
| 12969 | 1926125002 | K802586 | AMERICAN HEYER-SCHULTE LOW PROFILE VALVE | JXG | 1980-12-18 |
| 12966 | 1064178777 | K771529 | PERITONEAL INTRODUCER & SHEATH | GYK | 1977-08-16 |
| 12969 | 2024408817 | K760785 | MISHLER 2 CHAMB FLUSHING VALVE,ANTI-SYPH | JXG | 1976-11-01 |
| 12969 | 1398626056 | K760784 | MISHLER 2 CHAMB FLUSHING VALVE,STAND | JXG | 1976-11-01 |
| 12969 | 1954289082 | K760502 | VALVE, ANTI-SYPHON MODEL PUDENZE FLUSH. | JXG | 1976-08-30 |
| 12969 | 2020915121 | K760501 | VALVE, STANDARD MODEL PUDENZE FLUSHING | JXG | 1976-08-30 |
| 12969 | 1824474489 | K230427 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | 2023-07-11 |
| 12969 | 1746230866 | K221835 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | 2022-08-22 |
| 12969 | 1942806843 | K221763 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | 2022-07-15 |
| 12969 | 1850096439 | K191684 | MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System | JXG | 2019-10-11 |
| 12969 | 1670523884 | K190180 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | 2019-04-01 |
| 12969 | 1755722249 | K182809 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | 2018-12-07 |
| 12966 | 1345798448 | K161992 | Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems | JXG | 2016-09-22 |
| 12969 | 1345798448 | K161992 | Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems | JXG | 2016-09-22 |
| 12969 | 2016034898 | K161882 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | 2016-10-14 |
| 12969 | 1201944691 | K153041 | Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling | JXG | 2016-03-14 |
| 12966 | 1463597524 | K152897 | Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory | JXG | 2016-03-04 |
| 12969 | 1892720264 | K141674 | CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM | LFL | 2014-11-06 |
| 12966 | 1602032618 | K140722 | INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS | JXG | 2015-01-06 |
| 12969 | 2052951077 | K113570 | INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP | LFL | 2012-02-22 |
| 12969 | 1575045850 | K111741 | INTEGRA(TM) CUSA NXT(TM) BONE TIPS | LFL | 2011-08-23 |
| 12969 | 1776535364 | K102258 | CUSA NXT EXTENDED LENGTH TIP | LFL | 2011-06-10 |
| 12966 | 2062437439 | K101381 | HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS | JXG | 2011-07-07 |
| 12966 | 1196189534 | K093968 | OSV II LOW FLOW LOW PRO VALVE | JXG | 2010-01-22 |
| 12966 | 1889763245 | K092395 | OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM | JXG | 2009-11-19 |
| 12969 | 1156881718 | K092388 | DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO | GXQ | 2010-01-21 |
| 12969 | 1948464912 | K091302 | INTEGRA MOZAIK AND OS MOLDABLE MORSELS | MQV | 2009-12-04 |
| 12969 | 1737532453 | K090864 | CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM | LFL | 2009-05-08 |
| 12966 | 1680939872 | K082250 | AURAGEN CORTICAL SURFACE ELECTRODES | GYC | 2008-10-10 |
| 12966 | 1653267825 | K081773 | OSV II | JXG | 2008-11-06 |
| 12969 | 1795204646 | K081459 | CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM | LFL | 2008-08-13 |
| 12969 | 1988002658 | K072929 | LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030 | JXG | 2007-12-07 |
| 12969 | 1058030068 | K072207 | DURAGEN XS DURAL REGENERATION MATRIX | GXQ | 2007-08-23 |
| 12969 | 1886777497 | K071669 | INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP | LFL | 2007-08-17 |
| 12969 | 1087135514 | K062599 | MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS | JXG | 2006-09-27 |
| 12966 | 1523342892 | K053244 | LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT | GWM | 2006-05-10 |
| 12969 | 2026484921 | K051947 | RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE | LFL | 2005-08-22 |
| 12969 | 1922260101 | K043427 | DURAGEN II DURAL REGENERATION MATRIX | GXQ | 2005-01-12 |
| 12969 | 1808555202 | K042825 | ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM | JXG | 2004-12-21 |
| 12966 | 1582350957 | K042558 | EQUI-FLOW VALVE AND SHUNT SYSTEM | JXG | 2004-10-06 |
| 12966 | 1575710423 | K042192 | LOW FLOW OSV II HYDROCEPHALUS VALVE | JXG | 2004-09-02 |
| 12969 | 2020203644 | K041620 | NEURA WRAP NERVE PROTECTOR | JXI | 2004-07-16 |
| 12966 | 1344293041 | K040235 | LICOX PMO BRAIN MONITORING SYSTEM | GWM | 2004-04-20 |
| 12966 | 1710426978 | K033698 | CONTOUR-FLEX VALVE AND SHUNT SYSTEM | JXG | 2003-12-17 |
| 12966 | 1188378649 | K032817 | EXTERNAL DRAINAGE SET | JXG | 2003-10-06 |
| 12969 | 1188378649 | K032817 | EXTERNAL DRAINAGE SET | JXG | 2003-10-06 |
| 12969 | 1353387804 | K032693 | DURAGEN PLUS DURAL GRAFT MATRIX | GXQ | 2003-09-30 |
| 12969 | 1384582507 | K030289 | HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N | JXG | 2003-02-26 |
| 12969 | 1391792932 | K022554 | MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM | JXG | 2002-08-23 |
| 12969 | 1277946391 | K021989 | SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3 | LFL | 2002-09-13 |
| 12969 | 1159662740 | K011168 | NEUROGEN NERVE GUIDE | JXI | 2001-06-22 |
| 12969 | 1419770286 | K003229 | BIOPATCH ANTIMICROBIAL DRESSING | SEL | 2001-10-26 |
| 12966 | 1595200704 | K002765 | LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE | GWM | 2000-11-24 |
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INTEGRA NEUROSCIENCES IMPLANTS S.A.
INTEGRA NEUROSCIENCES
INTEGRA NEUROSCIENCES
INTEGRA NEUROSCIENCES IMPLANTS S.A.
INTEGRA NEUROSCIENCES, LTD.
INTEGRA NEUROSCIENCES IMPLANTS S.A.
INTEGRA NEUROSCIENCES IMPLANTS S.A.
INTEGRA NEUROSCIENCES IMPLANTS S.A.
INTEGRA NEUROSCIENCES IMPLANTS S.A.
INTEGRA NEUROSCIENCES
INTEGRA NEUROSCIENCES
INTEGRA NEUROSCIENCES
INTEGRA NEUROSCIENCES
Integra Neurosciences
2015-10-01
2016-08-12
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