FDA.reportPublic FDA data

INTEGRA LIFESCIENCES CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
11213081121308INTEGRA LIFESCIENCES CORPORATION1N2026-01-01105 and 109 MORGAN LANE PLAINSBORO NJ US 08536
30017000443001700044INTEGRA LIFESCIENCES SALES LLC1Y2026-01-011100 Campus Rd Princeton NJ US 08540
30034183253003418325Integra LifeSciences Corporation1Y2026-01-011100 Campus Road Princeton NJ US 08540
30041700643004170064Integra LifeSciences Braintree Inc.1N2026-01-01400b Wood Rd Braintree MA US 02184
30046088783004608878INTEGRA LIFESCIENCES CORPORATION1N2026-01-014900 CHARLEMAR DR., BUILDING A CINCINNATI OH US 45227
30143340383014334038Integra LifeSciences Production Corporation1N2026-01-0111 Cabot Blvd. Mansfield MA US 02048

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
10381780272618Omni-Tract® - Omni-Tract® Gelpi Point Retractor, Sharp+1(800)654-2873custsvcnj@integralife.com
10381780541370Durepair® - Durepair® Dura Regeneration Matrix 5cm x 5 cm+1(800)654-2873custsvcnj@integralife.com
10381780541387Durepair® - Durepair® Dura Regeneration Matrix 7.5cm x 7.5 cm+1(800)654-2873custsvcnj@integralife.com
10381780541400Durepair® - Durepair® Dura Regeneration Matrix 10cm x 12.5 cm+1(800)654-2873custsvcnj@integralife.com
10381780541417Durepair® - Durepair® Dura Regeneration Matrix 2.5cm x 2.5 cm+1(800)654-2873custsvcnj@integralife.com
20705031004334BioPatch™ - BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane absorptive foam with Chlorhexidine Gluconate (CHG) which inhibits bacterial growth under the dressing. The dressing is intended to be used to absorb exudate, cover a wound caused by vascular and nonvascular percutaneous medical devices during surgery, as well as reduce local infection and colonization of microorganisms.+1(800)654-2873custsvcnj@integralife.com
20705031004341BioPatch™ - BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane absorptive foam with Chlorhexidine Gluconate (CHG) which inhibits bacterial growth under the dressing. The dressing is intended to be used to absorb exudate, cover a wound caused by vascular and nonvascular percutaneous medical devices during surgery, as well as reduce local infection and colonization of microorganisms.+1(800)654-2873custsvcnj@integralife.com
20705031004358BioPatch™ - BioPatch™ Antimicrobial Dressing with Chlorhexidine Gluconate is a hydrophillic polyurethane absorptive foam with Chlorhexidine Gluconate (CHG) which inhibits bacterial growth under the dressing. The dressing is intended to be used to absorb exudate, cover a wound caused by vascular and nonvascular percutaneous medical devices during surgery, as well as reduce local infection and colonization of microorganisms.+1(800)654-2873custsvcnj@integralife.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
129671003374937P900033INTEGRA DERMAL REGENERATION TEMPLATEMGR1996-03-01
129781003374937P900033INTEGRA DERMAL REGENERATION TEMPLATEMGR1996-03-01
129671773461133P850010HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGELMF1985-11-08
129781773461133P850010HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGELMF1985-11-08
129671815776200P840062COLLACOTE(TM)LPG1985-11-08
129781815776200P840062COLLACOTE(TM)LPG1985-11-08
129671115660182P810006COLLASTATLMF1981-12-10
129781115660182P810006COLLASTATLMF1981-12-10
129781989060182P080013DURASEAL EXACT SPINE SEALANT SYSTEMNQR2009-09-04
129781438477060P040034DURASEAL DURAL SEALANT SYSTEMNQR2005-04-07
129781965663980P000057ASCENSION MCPNEG2001-11-19
129781518611594K993762I.CO.S SCREWHWC2000-02-04
129781276593041K993655MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUSGEI1999-12-21
129801276593041K993655MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUSGEI1999-12-21
2180011276593041K993655MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUSGEI1999-12-21
129782044560934K993653MICRO-FRANCE TROCARS AND ACCESSORIESHET2000-06-09
129802044560934K993653MICRO-FRANCE TROCARS AND ACCESSORIESHET2000-06-09
129781311601127K993594CONFORMAX MMLC VR1IYE1999-12-15
129781188657007K992732STERILE WATER & STERILE 0.9% SODIUM CHLORIDEFOZ2000-04-20
129781776172260K992591CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITSGWM1999-10-15
2180011776172260K992591CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITSGWM1999-10-15
129671804661727K992216BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANELYC1999-07-26
129781804661727K992216BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANELYC1999-07-26
129781428097792K992173SIPHONGUARD CSF CONTROL DEVICEJXG2000-04-07
2180011428097792K992173SIPHONGUARD CSF CONTROL DEVICEJXG2000-04-07
129782065150661K991873KMI WRIST FUSION SYSTEMHRS1999-08-17
129802065150661K991873KMI WRIST FUSION SYSTEMHRS1999-08-17
129782047955677K991566SOLUSTAPLEJDR1999-08-03
129781733607005K991523TLC PEDIATRIC FRAME, MODEL TLC-SYSIYE1999-07-30
129781805210830K991482UNI-CLIP STAPLEJDR1999-06-03
129781202346969K991477SPIN SNAP-OFF SCREWHWC1999-07-14
129781088532226K991413CODMAN ETHISORB DURA PATCHGXQ2000-03-13
2180011088532226K991413CODMAN ETHISORB DURA PATCHGXQ2000-03-13
129781093635698K991222CODMAN MICROSENSOR VENTRICULAR CATHETER KITGWM1999-07-09
2180011093635698K991222CODMAN MICROSENSOR VENTRICULAR CATHETER KITGWM1999-07-09
129781584601322K990622BOLD SCREWHWC1999-04-29
129781421461965K983603REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAMEHAW1998-11-10
129801421461965K983603REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAMEHAW1998-11-10
129781894017646K982549RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLCIYE1998-12-30
129781783902218K982379SUNDT SLIM-LINE ANEURYSM CLIP APPLIERHCI1998-12-18
2180011783902218K982379SUNDT SLIM-LINE ANEURYSM CLIP APPLIERHCI1998-12-18
129782017435437K982365ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMATDXC1999-04-08
129802017435437K982365ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMATDXC1999-04-08
2180012017435437K982365ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMATDXC1999-04-08
129781265329691K982294XOMED SILICONE PRE-FORM BLOCKSKHJ1998-09-18
2180011265329691K982294XOMED SILICONE PRE-FORM BLOCKSKHJ1998-09-18
129671604503948K982180DURAGEN DURAL GRAFT MATRIXGXQ1999-07-06
129781604503948K982180DURAGEN DURAL GRAFT MATRIXGXQ1999-07-06
129781880935097K981919BISSINGER CABLES, CAT. NO. 801000XXGEI1998-08-06
129801880935097K981919BISSINGER CABLES, CAT. NO. 801000XXGEI1998-08-06
129781284442575K981751SINUSCOPE AND ACCESSORIESEOB1998-08-13
129781145214770K981597RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITYIYE1998-10-09
129801145214770K981597RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITYIYE1998-10-09
129781408053185K981262CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEMLFL1998-07-06
129781403741746K981194FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANTKWH1998-06-30
129781076531964K980861DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGELMGQ1998-05-20
129781869570346K980791DUMEX PAK-ITS WOVEN RIBBON PACKINGEFQ1998-04-29
129781642441399K980584ATLASPLANHAW1998-05-18
129801642441399K980584ATLASPLANHAW1998-05-18
129781827908289K980448MODEL PS-1 PENA MUSCLE STIMULATORIPF1998-04-03
129781293444010K974739HAKIM PROGRAMMABLE VALVE SYSTEMJXG1998-07-01
2180011293444010K974739HAKIM PROGRAMMABLE VALVE SYSTEMJXG1998-07-01
129781578640015K974726SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETERJXG1998-03-18
129781964117342K974708GEMINI STANDARD AND MINI VALVESJXG1998-03-10
129781839003887K974088CODMAN INTRACRANIAL BOLTGWM1998-01-09
2180011839003887K974088CODMAN INTRACRANIAL BOLTGWM1998-01-09
129781505347487K973774CODMAN HAKIM MICRO PRECISION VALVEJXG1997-12-29
2180011505347487K973774CODMAN HAKIM MICRO PRECISION VALVEJXG1997-12-29
129781238886251K973525MAURICE WORLDWIDE SHUNT SYSTEMJXG1997-12-16
129781027266655K972994EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMSJXG1997-11-03
129781608911441K971617ENDOSCOPIC VENTRICULAR CATHETERJXG1997-07-31
129781894235753K970983PERITONEAL/CARDIAC CATHETERJXG1997-06-13
129781085205304K970910XOMED SILICONE BLOCK/STRIPKHJ1997-05-02
2180011085205304K970910XOMED SILICONE BLOCK/STRIPKHJ1997-05-02
129781297804740K970658LUMBAR DRAINAGE ACCESSORY KITJXG1997-05-19
129781389925282K964371SHUNT TAP WITH ICP MONITORING ACCESS PORTJXG1997-01-31
129781964666166K963802SHUNT TAPJXG1996-12-12
129781343517402K963499MIRROR FINISH BIPOLAR FORCEPSGEI1996-10-08
2180011343517402K963499MIRROR FINISH BIPOLAR FORCEPSGEI1996-10-08
129781214703546K962928COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)GWM1996-12-20
129781815261204K962545DENTAL, MEDICAL INSTRUMENT CASES & CASSETTEKCT1997-03-07
129781874914182K962540E-TYPE CONTRA ANGLE NAC-EEGS1996-09-12
2180011874914182K962540E-TYPE CONTRA ANGLE NAC-EEGS1996-09-12
129781292517985K962155GILL-THOMAS-COSMAN(GTC) DENTAL TRAYIYE1996-08-22
129801292517985K962155GILL-THOMAS-COSMAN(GTC) DENTAL TRAYIYE1996-08-22
129781745465512K961859NOVUS STANDARD AND PEDIATRIC VALVESJXG1996-12-16
129781856315332K961858COSGROVE DEPTH ELECTRODE KIT(CDEK)HAW1996-08-07
129801856315332K961858COSGROVE DEPTH ELECTRODE KIT(CDEK)HAW1996-08-07
129781254607734K961113CNS INTERCHANGEABLE BIT CRANIAL DRILLHBG1996-06-05
129781650302083K960815DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLLNAD1996-04-29
129781014476569K960807TEW CRANIAL/SPINAL RETRACTOR MODEL A1090GZT1996-05-17
129801014476569K960807TEW CRANIAL/SPINAL RETRACTOR MODEL A1090GZT1996-05-17
129782028583999K960692SUBTALAR MBA SYSTEMHWC1996-07-23
129802028583999K960692SUBTALAR MBA SYSTEMHWC1996-07-23
129782043936071K960248GENERAL PROCEDURE KITFMF1996-04-12
129781641649783K960159CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)JXG1996-10-25
129781201408899K960100SPINAL SPECIALTIES NERVE BLOCK TRAYCAZ1996-04-24
129781136422705K960082DISCOGRAPHY KITIZG1996-03-21
129781909342503K955832CORDIS VENTRICULAR ANTECHAMBER (VA)JXG1996-03-25
129782056522732K955265CORDIS SHARP-ENDED STYLET; BLUNT-ENDED STYLET; CYST PUNCTURE CATHETERJXG1996-12-20
129782021815686K954743DERMAGRAN WOUND DRESSING CLEANER W/ZINCFRO1995-11-02
129781859661247K954739DERMAGRAN HYDROPHILIC OINTMENTFRO1995-11-02
129781059353929K954738DERMAGRAN HYDROPHILIC WOUND DRESSINGMGP1995-11-02
129781681748476K953124MAYFIELD RADIOLUCENT 2000 SKULL CLAMPHBL1996-02-09
129801681748476K953124MAYFIELD RADIOLUCENT 2000 SKULL CLAMPHBL1996-02-09
129781758140045K950820SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLEBSP1995-06-30
129781977942307K950646INTEGRATORLXM1996-04-30
2180011977942307K950646INTEGRATORLXM1996-04-30
129781655835660K950315CORDIS CSF RESERVOIRLKG1995-05-09
129781752908724K950132DUMEX WET DRESSINGSFRO1995-03-01
129781435460671K946326DUTEX GAUZE BANDAGEEFQ1995-01-24
129781481333891K945830DUFLEX CONFORMING BANDAGE (STERILE/NON-STERILE)EFQ1995-01-11
129781202396442K945802DERMAGRAN WOUND CLEANSER WITH ZINCKMF1995-02-27
129781347427456K945585COMAN(R) CU-11 MODEL NUMBER 82-6634GWM1995-10-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JXG1192024-01-17
GEI412021-12-02
GWM402024-02-04
HRS342013-08-07
HBL302014-11-24
GXQ272016-11-02
HWC262015-10-29
KGN252024-07-11
LFL232023-07-11
GCJ232012-09-11
HAW162016-12-06
FRO162015-11-19
KCT152024-03-22
FTM142019-02-07
IYE142010-04-22
MQV122014-08-01
DXC112013-05-14
PGW102023-07-21
LRC102020-08-27
GWG82025-04-09
HBF82019-01-20
HSN82018-12-18
JXI82017-01-06
JDR82013-05-03
HBG71996-06-05
DWP62019-09-03
JOJ62016-06-28
JWJ62014-03-24
EOB62011-05-27
KWD62010-01-14
HCA62003-05-14
LYC61999-07-26
GYK61993-08-23
LMF61985-11-08
KWS52015-12-23
HAE52015-04-16
KNF52012-02-08
HBA42020-11-20
HSB42018-11-02
EJI42014-10-30

PMA#

Helistat® and Helitene® Absorbable Collagen Hemostatic Agents

2022-12-19

INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08540 PMA NumberP850010 Supplement NumberS104 Date Received11/21/2022 Decision Date12/19/2022 Product Code LMF  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supple...

DuraSeal Dural Sealant System

2022-10-07

INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP040034 Supplement NumberS035 Date Received09/07/2022 Decision Date10/07/2022 Product Code NQR  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Proc...

DuraSeal Exact Spine Sealant System

2022-10-07

INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08536 PMA NumberP080013 Supplement NumberS024 Date Received09/07/2022 Decision Date10/07/2022 Product Code NQR  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Proc...

Helistat® and Helitene® Absorbable Collagen Hemostatic Agents

2022-07-06

INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08540 PMA NumberP850010 Supplement NumberS103 Date Received06/06/2022 Decision Date07/06/2022 Product Code LMF  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supple...

Helistat® and Helitene® Absorbable Collagen Hemostatic Agents

2022-05-20

INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08540 PMA NumberP850010 Supplement NumberS102 Date Received04/20/2022 Decision Date05/20/2022 Product Code LMF  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supple...

Helistat and Helitene Absoibable Collagen Hemostatic Agents

2022-04-20

INTEGRA LIFESCIENCES CORPORATION311 Enterprise Dr.plainsboro, NJ 08540 PMA NumberP850010 Supplement NumberS100 Date Received03/21/2022 Decision Date04/20/2022 Product Code LMF  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supple...

200 records. Showing 1-40. Next

PMN#

100 records. Showing 1-40. Next

GUDID#

Integra Mishler Dual Chamber Flushing Valve - VALVE FLUSH F/B D/C W/CONNECTORThe Integra Mishler Dual Chamber Flushing valve, Flat Bottom Design incorporates two separate interior chambers to provide two-way flow control when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. This silicone elastomer flushing valve is available with or without an integral Anti-Siphon Device. The flat bottom configuration eliminates the need for a formal burr hole, provides greater latitude in positioning the flushing valve and allows the ventricular catheter to be revised without disturbing the flushing valve. Due to the dual chamber feature, the proximal and distal catheters may be flushed separately or simultaneously. The flow of CSF from the ventricular catheter is controlled by a miter valve located on the vertical chamber divider. This valve is designed to open under a medium positive ventricular pressure and close under a negative pressure. The flushing valve dome is marked with an arrow to indicate the CSF flow direction. The flange overlying the skull contains sutural holes to facilitate securing the device to the periosteum.

Integra Lifesciences Corporation

2015-09-22

200 records. Showing 1-40. Next