FDA.reportPublic FDA data

Crosstex International

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
13191301319130Crosstex International1Y2026-01-016789 WEST HENRIETTA RD. Rush NY US 14543
30036756583003675658CROSSTEX INTERNATIONAL, INC.1N2026-01-01621 Hurricane Shoals Rd NW Ste G LAWRENCEVILLE GA US 30046
30060089843006008984CROSSTEX INTERNATIONAL, INC.1N2026-01-01534 VINE STREET SHARON PA US 16146
17250503003310450CROSSTEX INTERNATIONAL, INC. formerly (CONFIRM MONITORING)1N2020-04-25109 INVERNESS DR. EAST UNIT F Centennial CO US 80112
20325733003706417CROSSTEX INTERNATIONAL, INC.1N2020-04-2514059 STAGE RD. Santa Fe Spgs CA US 90670
24337732433773CROSSTEX INTERNATIONAL, INC.1Y2020-04-2510 RANICK RD. HAUPPAUGE NY US 11788

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
00732224005508DentaPure 365-Day Independent Water Bottle Cartridge - Water Purification Bottle Cartridge+1(585)359-0167regulatoryaffairs@hu-friedy.com
00732224005515DentaPure Water Purification Municipal Cartridge - Water Purification Municipal Cartridge+1(585)359-0167regulatoryaffairs@hu-friedy.com
10732224000050Crosstex International - (POUCH 5.25X10 SELFSEAL)+1(800)483-7433care@hu-friedy.com
30732224120233Isofluid Surgical Masks - With Fog Free Strip and Shield. ASTM Level 1, Blue+1(585)359-0167regulatoryaffairs@hu-friedy.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
72431608476020K993793GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVELYY2000-01-12
72431718089208K992893DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGEEIA1999-09-08
310471987289172K992893DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGEEIA1999-09-08
72431326979398K992868DENTAPURE DP40 CARTRIDGEEIA1999-09-07
310471816070228K992868DENTAPURE DP40 CARTRIDGEEIA1999-09-07
72431553208622K990228GUTHRIE PRIME POWDER-FREELYY1999-02-19
72431649785661K990013EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVESLZA1999-03-23
72431811018528K984187CROSSTEX NON-WOVEN SPONGESEFQ1999-02-18
310471873602511K974062MEDSCI 3% GLUTARALDEHYDEMED1998-09-02
310471367907290K973062TWIST RECIPROCATING DISPOSABLE PROPHY ANGLEEFA1997-10-09
72431426618240K973062TWIST RECIPROCATING DISPOSABLE PROPHY ANGLEEFA1997-10-09
310471829362396K971432PROSPOREFRC1997-05-20
72431264612590K955426STERITEC CROSS-CHECKSJOJ1996-03-12
310471321677692K955426STERITEC CROSS-CHECKSJOJ1996-03-12
72431547632853K941327CROSSTEX SELF-SEALING STERILIZATION POUCHKCT1994-12-22
72461547632853K941327CROSSTEX SELF-SEALING STERILIZATION POUCHKCT1994-12-22
310471762262511K941327CROSSTEX SELF-SEALING STERILIZATION POUCHKCT1994-12-22
310471360712584K931202STERILIZATION WRAP-STERISHEETFRG1993-12-16
72431401971834K931202STERILIZATION WRAP-STERISHEETFRG1993-12-16
1260001100831978K905425SPORVIEWFRC1992-03-27
310471243269389K905425SPORVIEWFRC1992-03-27
72431462244966K895077SURGICAL MASK/DENTAL MASKFXX1989-11-03
310471969466431K890765STRIP, STERILIZATION INDICATOR; STEAM OR E.O. GASJOJ1989-08-07
310471090007725K890763LABEL, STERILIZATION INDICATOR; DUAL STEAM/E.O.GASJOJ1989-08-07
310471874891901K890761STRIP, STERILIZATION INDICATOR; DRY HEATJOJ1989-08-07
310471153947126K890760STRIP, STERILIZATION INDICATOR, E.O. GASJOJ1989-08-07
310471128396136K890759STRIP, STERILIZATION INDICATOR; STEAMJOJ1989-08-07
310471531379231K890757C-VAPOR STERILIZATION INDICATOR, CHEMICAL VAPORJOJ1989-08-07
72431398272698K890755SEALING TAPE, STERILIZATION INDICATOR; STEAMJOJ1989-08-07
310471770289637K890755SEALING TAPE, STERILIZATION INDICATOR; STEAMJOJ1989-08-07
310471537776172K890754SPORVIEW CULTURE MEDIAFRC1989-11-17
310471455424682K882756LANTOR CUBE STERILIZER TEST PACKJOJ1988-10-06
72431993114770K861727COTTON FILLED GAUZE SPONGES 2 X 2EFN1986-07-10
72431008455723K861338DENTAL COTTON ROLLS, STERILE AND NON-STERILEEFN1986-08-06
72431002295945K852170EZX YELLOW, BLUE OR ORANGEEGZ1985-09-05
310471512885574K852170EZX YELLOW, BLUE OR ORANGEEGZ1985-09-05
310471647069058K213412VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CMJOJ2022-01-21
310471663068903K200096Crosstex VH2O2 Chemical IndicatorsJOJ2021-07-15
310471600777064K191741Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization TapeJOJ2019-08-02
310471632642185K172432SporView Rapid Read Biological IndicatorFRC2017-12-12
310471156113992K171287Sporview VH202 BIFRC2018-02-01
310471960775276K143520SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External Indicator (Label)JOJ2015-06-09
310471690881747K140620SPORVIEW PLUS BI TEST PACKFRC2014-08-07
310471651082040K140566SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPEJOJ2014-11-24
310471745696068K133204AIRVIEW MINI OWIE DICK TEST PACKJOJ2014-05-05
310471351616226K133070SURGICAL FACE MASK (Ear Loops and Tie-on)FXX2015-06-22
310471750258870K130211AIRVIEW BOWIE DICK; TEST PACK, INDICATOR SHEETSJOJ2013-07-05
72431775480904K123162U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLLFRG2014-02-26
310471161402754K122024SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATORFRC2013-11-26
1260001545136250K122024SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATORFRC2013-11-26
1260001750420223K111515SPSMEDICAL SPORVIEW STEAM BIFRC2012-02-01
310472016181329K111515SPSMEDICAL SPORVIEW STEAM BIFRC2012-02-01
72431857296110K111343CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSSFXX2011-10-06
310471869902729K111343CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSSFXX2011-10-06
310471119323572K103303CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITEFXX2010-12-23
72431611906184K103303CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITEFXX2010-12-23
310471844054891K102363SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004JOJ2011-01-27
72431722423397K092824N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695MSH2009-10-21
72431161756572K082258CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISORFXX2008-10-16
310471239531932K082258CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISORFXX2008-10-16
310471267013499K081879SPSMEDICAL SPORVIEW PA CULTURE SETMRB2008-07-30
72431235510053K080814VOCO PROFLUORID VARNISHLBH2008-07-24
310471843431486K063799STEAMPLUS STEAM INTEGRATORJOJ2007-01-05
310471061734125K061375RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730MSH2006-11-17
310471054558830K041099MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIPFRC2004-05-06
1260001899173884K041099MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIPFRC2004-05-06
310471896591116K040098VARNISHAMERICALBH2004-02-04
72431983670795K040098VARNISHAMERICALBH2004-02-04
310471686092726K030603PROANGLE DISPOSABLE PROPHY ANGLEEGS2003-04-14
72432005062606K030603PROANGLE DISPOSABLE PROPHY ANGLEEGS2003-04-14
310471226222390K023716SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIPFRC2002-12-05
1260001769971887K023716SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIPFRC2002-12-05
310471428582044K020409STEAMPLUS STERILIZATION TESTJOJ2002-07-18
72431033872374K012602CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEXFXX2002-01-22
72431849754900K003985POWDERFREE NITRILE PATIENT EXMINATION GLOVELZA2001-02-09
72431351673750K002719FORMULA ONE POWDERED LATEX EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM 200 MICROGRAMS OR LESS AND MADE FROM ALYY2001-01-26
72431025709199
72431026519823
72441026519823
72431037633289
72431043636726
72431062297617
72431157602506
72441157602506
72451157602506
72431158936891
72431186455529
72431187172945
72431277883759
72431284772872
72431388265113
72431434302617
72431484236499
72431496258622
72431549808486
72431670175646
72431694716429
72431760298408
72431777250503
72431801919735
72431840633358
72431862035984
72431912631721
72432047650415
310471003811406
72451026519823
310471110248943
310471174403352
310471197762513
310471199798010
310471217677900
72461231222751
310471255609134
310471385688660
310471428708190
72461549808486
310471580010467
310471601522422
310471633161395

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JOJ212022-01-21
FRC152018-02-01
FXX92015-06-22
EIA41999-09-08
FRG32014-02-26
LBH32008-07-24
LYY32001-01-26
KCT31994-12-22
MSH22009-10-21
EGS22003-04-14
LZA22001-02-09
EFA21997-10-09
EFN21986-08-06
EGZ21985-09-05
MRB12008-07-30
EFQ11999-02-18
MED11998-09-02

NDC#

Zap APF

Crosstex International Inc.

Sodium Fluoride

Zap APF

Crosstex International Inc.

Sodium Fluoride

Zap APF

Crosstex International Inc.

Sodium Fluoride

Zap APF

Crosstex International Inc.

Sodium Fluoride

Zap APF

Crosstex International Inc.

Sodium Fluoride

Zap APF

Crosstex International Inc.

Sodium Fluoride

Zap APF

Crosstex International Inc.

Sodium Fluoride

Zap APF

Crosstex International Inc.

Sodium Fluoride

Zap APF

Crosstex International Inc.

Sodium Fluoride

PMN#

GUDID#

80 records. Showing 1-40. Next