FDA.reportPublic FDA data

INTEGRA YORK PA, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
25231902518040INTEGRA YORK PA, INC.1N2020-04-25589 Davies Dr York PA US 17402

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
H83440910Integra® Miltex® - Spatula and Packer, Double-Ended, Oval Spatula and Packer+1(800)654-2873custsvcnj@integralife.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
129811276593041K993655MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUSGEI1999-12-21
129812044560934K993653MICRO-FRANCE TROCARS AND ACCESSORIESHET2000-06-09
129811421461965K983603REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAMEHAW1998-11-10
129811265329691K982294XOMED SILICONE PRE-FORM BLOCKSKHJ1998-09-18
129811880935097K981919BISSINGER CABLES, CAT. NO. 801000XXGEI1998-08-06
129811284442575K981751SINUSCOPE AND ACCESSORIESEOB1998-08-13
129811085205304K970910XOMED SILICONE BLOCK/STRIPKHJ1997-05-02
129811815261204K962545DENTAL, MEDICAL INSTRUMENT CASES & CASSETTEKCT1997-03-07
129811977942307K950646INTEGRATORLXM1996-04-30
129811916327773K945541SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALEHKY1995-05-08
129812034426250K945266OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPESGCJ1995-02-23
129811630812658K944870JARIT ENDOSCOPES, MODELS 600-600; 600-630; 600-650; AND 600-680GCJ1994-11-02
129811301240529K944670JARIT RECOMMENDED SINUS INSTRUMENTSEOB1995-02-02
129811591075748K944656OPTUS SINUSCOPES AND ACCESSORIESEOB1995-01-26
129811670417272K941565JARIT RECOMMENDED SINUS INSTRUMENTSEOB1994-05-16
129811195295229K941541HSV LAPAROSCOPY SETGCJ1994-05-16
129811973151328K933728JARIT SURGICAL INSTRUMENTS: CATALOG 615-330, 615-331, 615-334, 615-335, 615-338, 615-339GEI1994-02-23
129811920821367K932456JARIT SURGICAL INSTRUMENTSKNF1994-04-21
129811811406224K931959JARIT SURGICAL INSTRUMENTSGEI1993-10-05
129811545794415K931928JARIT SURGICAL INSTRUMENTSGCJ1993-11-10
129811699505425K931202STERILIZATION WRAP-STERISHEETFRG1993-12-16
129812010114609K923689SURGISTAR BLADESGDX1992-09-09
129811092338336K902818MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENTHBG1990-09-20
129811204477490K900533DISPOSABLE BIPOLAR COAGULATING FORCEPSGEI1990-04-09
129811221821511K890765STRIP, STERILIZATION INDICATOR; STEAM OR E.O. GASJOJ1989-08-07
129811664753786K890761STRIP, STERILIZATION INDICATOR; DRY HEATJOJ1989-08-07
129811876307855K890759STRIP, STERILIZATION INDICATOR; STEAMJOJ1989-08-07
129811358644048K890755SEALING TAPE, STERILIZATION INDICATOR; STEAMJOJ1989-08-07
129811140705657K864387LUXTEC FIBEROPTIC CABLESEQH1987-05-22
129811569970218K864385LUXTEC LIGHT SOURCESFCW1987-01-13
129811845845260K864380LUTEX HEADLIGHT SYSTEMSFST1986-11-19
129811214987659K831236BIPOLAR CARDGEI1983-06-02
129811095433935K191741Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization TapeJOJ2019-08-02
129811106900700K150428Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison RongeursHAE2015-04-16
129811562832410K150024Bissinger Monopolar CablesGEI2015-02-20
129811745461274K142414Miltex N-Tralig Intraligamentary SyringeEJI2014-10-30
129811943695468K134047JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPSHCZ2014-04-11
129811571029755K131407BAHADIR STERILIZATION TRAYSKCT2014-08-12
129811687623266K130273PANPAC VAGINAL DILATORSHDX2013-08-08
129811669413470K120012INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTSGCJ2012-09-11
129811836287221K112090BAHADIR STERILIZATION TRAYSKCT2012-06-07
129811419483138K110528INTEGRA LED SURGICAL HEADLIGHT SYSTEMFSR2011-05-11
129812020418372K103726JARIT TAKE-APART ENDOSCOPIC INSTRUMENTSKNF2012-02-08
129811346042386K102921ENDOSCOPIC MONOPOLAR INSTRUMENTS AND ACCESSORIESGEI2011-12-20
129812057654668K102146BAHADIR STERILIZATION TRAYSKCT2010-11-18
129811162480140K101653MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTESKCT2010-08-02
129811369446444K100736KIRSCHNER AND GUIDE WIRESHTY2010-09-10
129811665958895K092982THE PANPAC SUCTION CURETTEHHK2010-07-26
129811037135377K092981PANPAC VAGINAL PESSARYHHW2010-07-22
129811661610256K092227JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURSHAE2010-02-17
129811362165234K091721CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23GEH2009-10-02
129811164768729K083796MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHTEJI2009-03-09
129811256845851K082349JARIT HULKA UTERINE TENACULUM FORCEPSHDC2008-11-21
129811624616522K081477LUXTEC MLX LIGHT SOURCEFCW2008-06-18
129811101794646K073450SUTTER ELECTROSURGICAL CABLESGEI2008-03-17
129811954695579K072563MILTEX RIGID CONTAINER SYSTEMSKCT2008-02-12
129812033131406K071218PROXENON 350, MODEL 902XXFST2007-06-14
129811538589518K070509FISSO HOLDING SYSTEMGCJ2007-03-22
129812055865231K061033MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS)KCT2006-12-12
129811534676807K060233TROKAMED GMBH ENDOSCOPES AND ACCESSORIESGCJ2006-07-19
129811745543167K052745ASSISTO ARM SYSTEMSGWG2005-11-23
129811628599486K051429CLARIS NON-STICK BIPOLAR FORCEPSGEI2005-07-29
129811384278326K050570MILTEX RIGID STERILIZATION CONTAINER SYSTEMKCT2005-07-25
129811237549402K043013MILTEX LAPAROSCOPIC INSTRUMENTSHET2005-03-04
129811459986947K040223POLYVAC INSTRUMENT DELIVERY SYSTEMKCT2004-10-22
129811604033430K033762SERRALAPGGAM2004-03-15
129811409213763K033660STORZ RANEY SCALP CLIP, MODEL 1-20-004-05HBO2004-01-07
129811081803248K032743APEX NRGLQY2004-03-15
129811506026459K020901SERRALSILKGAP2002-04-26
129811888674827K020597SERRALGUTGAL2002-08-14
129811755580760K012105POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEMKCT2002-08-02
129811567439435K003380BIOTEQUE VAGINAL DILATORHDX2001-01-29
129811002506365
129811003372883
129811003603889
129811005134996
129811007022935
129811008434650
129811012811137
129811017858284
129811018356107
129811022877110
129811046782913
129811047779148
129811048191559
129811050733655
129811053590093
129811056287564
129811060932978
129811063627872
129811064297978
129811065521231
129811070497949
129811070848410
129811075015348
129811075128803
129811075911886
129811077277435
129811079093847
129811086597175
129811087047763
129811103452066
129811103927945
129811105110666
129811106195673
129811106864949
129811106871027
129811108045157
129811111426585
129811116215491
129811123992094
129811126284293
129811139346937
129811143209123
129811145048078
129811145531493
129811149593294
129811154026512
129811156060810
129811159013706

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI102015-02-20
KCT102014-08-12
GCJ72012-09-11
JOJ52019-08-02
EOB41998-08-13
HAE22015-04-16
EJI22014-10-30
HDX22013-08-08
KNF22012-02-08
FCW22008-06-18
FST22007-06-14
HET22005-03-04
KHJ21998-09-18
HCZ12014-04-11
FSR12011-05-11
HTY12010-09-10
HHK12010-07-26
HHW12010-07-22
GEH12009-10-02
HDC12008-11-21
GWG12005-11-23
GAM12004-03-15
LQY12004-03-15
HBO12004-01-07
GAL12002-08-14
GAP12002-04-26
HAW11998-11-10
LXM11996-04-30
HKY11995-05-08
FRG11993-12-16
GDX11992-09-09
HBG11990-09-20
EQH11987-05-22

GUDID#