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Data / Medical devices / United States / Crosstex International

Crosstex International: FDA-registered device maker in Rush, NY, United States, 37 510(k) clearances

Crosstex International is registered with the FDA (registration 1319130) in Rush, NY, United States. It lists 33 device types. The FDA files 37 510(k) clearances under its listings, the newest dated January 21, 2022. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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FDA registration number
1319130
Address
6789 West Henrietta RD., Rush, NY, United States, 14543
Owner or operator
SPS/Crosstex International (1319130)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed
July 11, 1988
Registered through
2027
Brand names listed
1/2" DUAL dot, 2000/rl, Advantage, Advantage Plus, Aesculap EO Gas dot 3/8", 10,000/RL (FAX), Aesculap, Paper Label Stock-continuous roll, 450 LF/rl, Air/Water Syringe Tips, All-Gauze Sponges Premium, Barrier Film and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorber, Saliva, PaperKHR1Specification developeraccessdata.fda.gov
Agent, Polishing, Abrasive, Oral CavityEJR1Repackager or relabeleraccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Repackager or relabeleraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Manufacturer, Specification developeraccessdata.fda.gov
Block, HeatingJRG1Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Chair, Dental, Without Operative UnitNRU1Repackager or relabeler, Specification developeraccessdata.fda.gov
Cleaner, Ultrasonic, Medical InstrumentFLG1Repackager or relabeleraccessdata.fda.gov
Container, Liquid Medication, GraduatedKYW1Repackager or relabeleraccessdata.fda.gov
Cotton, RollEFN1Repackager or relabeleraccessdata.fda.gov
Dam, RubberEIE1Repackager or relabeleraccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Repackager or relabeleraccessdata.fda.gov
Disinfectant, Medical DevicesLRJ1Repackager or relabeleraccessdata.fda.gov
Dress, SurgicalFYE1Manufactureraccessdata.fda.gov
Evacuator, Oral CavityEHZ1Repackager or relabeleraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Handpiece, Belt And/Or Gear Driven, DentalEFA1Repackager or relabeleraccessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, DentalEGS1Repackager or relabeler, Specification developeraccessdata.fda.gov
Holder, Film, X-RayEGZ1Repackager or relabeleraccessdata.fda.gov
Indicator, Biological Sterilization ProcessFRC2Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Indicator, Physical/Chemical Sterilization ProcessJOJ2Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Instrument, Contouring, Matrix, OperativeEKF1Repackager or relabeleraccessdata.fda.gov
Mask, SurgicalFXX2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Mouthpiece, Saliva EjectorDYN1Repackager or relabeleraccessdata.fda.gov
Paper, ArticulationEFH1Repackager or relabeleraccessdata.fda.gov
Respirator, SurgicalMSH2Repackager or relabeleraccessdata.fda.gov
Sterilant, Medical DevicesMED2Repackager or relabeleraccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Repackager or relabeler, Specification developeraccessdata.fda.gov
Tray, Fluoride, DisposableKMT1Repackager or relabeler, Specification developeraccessdata.fda.gov
Unit, Operative DentalEIA1Repackager or relabeleraccessdata.fda.gov
Unit, Operative Dental, AccessoriesNRD1Repackager or relabeleraccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Repackager or relabeler, Specification developeraccessdata.fda.gov
Varnish, CavityLBH2Repackager or relabeleraccessdata.fda.gov
Wrap, SterilizationFRG2Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 21, 2022K213412VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CMJOJSubstantially EquivalentSteris Corparationaccessdata.fda.gov
July 15, 2021K200096Crosstex VH2O2 Chemical IndicatorsJOJSubstantially EquivalentCrosstex International, Inc. (A Cantel Medical Company)accessdata.fda.gov
August 2, 2019K191741Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization TapeJOJSubstantially EquivalentIntertape Polymer, Inc.accessdata.fda.gov
June 22, 2015K133070SURGICAL FACE MASK (Ear Loops and Tie-on)FXXSubstantially EquivalentBh Medical Products Co., Ltd.accessdata.fda.gov
August 7, 2014K140620SPORVIEW PLUS BI TEST PACKFRCSubstantially EquivalentCrosstex Internationalaccessdata.fda.gov
May 5, 2014K133204AIRVIEW MINI OWIE DICK TEST PACKJOJSubstantially EquivalentCrosstex Internationalaccessdata.fda.gov
November 26, 2013K122024SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATORFRCSubstantially EquivalentSpsmedical Supply Corp.accessdata.fda.gov
July 5, 2013K130211AIRVIEW BOWIE DICK; TEST PACK, INDICATOR SHEETSJOJSubstantially EquivalentSpsmedical Supply Corp.accessdata.fda.gov
February 1, 2012K111515SPSMEDICAL SPORVIEW STEAM BIFRCSubstantially EquivalentSpsmedical Supply Corp.accessdata.fda.gov
October 6, 2011K111343CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSSFXXSubstantially EquivalentCrosstex International, Inc.accessdata.fda.gov
December 23, 2010K103303CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITEFXXSubstantially EquivalentCrosstex International, Inc.accessdata.fda.gov
October 16, 2008K082258CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISORFXXSubstantially EquivalentCrosstex Internationalaccessdata.fda.gov
January 5, 2007K063799STEAMPLUS STEAM INTEGRATORJOJSubstantially EquivalentSpsmedical Supply Corp.accessdata.fda.gov
November 17, 2006K061375RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730MSHSubstantially EquivalentLouis M. Gerson Co., Inc.accessdata.fda.gov
May 6, 2004K041099MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIPFRCSubstantially EquivalentSpsmedical Supply Corp.accessdata.fda.gov
February 4, 2004K040098VARNISHAMERICALBHSubstantially EquivalentMedical Products Laboratories, Inc.accessdata.fda.gov
April 14, 2003K030603PROANGLE DISPOSABLE PROPHY ANGLEEGSSubstantially EquivalentPac-Dent International (Suzhou), Ltd.accessdata.fda.gov
December 5, 2002K023716SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIPFRCSubstantially EquivalentSpsmedical Supply Corp.accessdata.fda.gov
July 18, 2002K020409STEAMPLUS STERILIZATION TESTJOJSubstantially EquivalentSpsmedical Supply Corp.accessdata.fda.gov
September 8, 1999K992893DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGEEIASubstantially EquivalentMrlb Intl., Inc.accessdata.fda.gov
September 7, 1999K992868DENTAPURE DP40 CARTRIDGEEIASubstantially EquivalentMrlb Intl., Inc.accessdata.fda.gov
September 2, 1998K974062MEDSCI 3% GLUTARALDEHYDEMEDSubstantially EquivalentMedsci, Inc.accessdata.fda.gov
October 9, 1997K973062TWIST RECIPROCATING DISPOSABLE PROPHY ANGLEEFASubstantially EquivalentMedidenta Intl., Inc.accessdata.fda.gov
May 20, 1997K971432PROSPOREFRCSubstantially EquivalentRaven Biological Laboratories, Inc.accessdata.fda.gov
March 12, 1996K955426STERITEC CROSS-CHECKSJOJSubstantially EquivalentSteritec Products Mfg Co, Inc.accessdata.fda.gov
December 22, 1994K941327CROSSTEX SELF-SEALING STERILIZATION POUCHKCTSubstantially EquivalentCross Country Paper Products Corp.accessdata.fda.gov
December 16, 1993K931202STERILIZATION WRAP-STERISHEETFRGSubstantially EquivalentArjo Wiggins Medical, Inc.accessdata.fda.gov
March 27, 1992K905425SPORVIEWFRCSubstantially EquivalentSpsmedical Supply Corp.accessdata.fda.gov
November 17, 1989K890754SPORVIEW CULTURE MEDIAFRCSubstantially EquivalentSpsmedical Supply Corp.accessdata.fda.gov
August 7, 1989K890765STRIP, STERILIZATION INDICATOR; STEAM OR E.O. GASJOJSubstantially EquivalentSpsmedical Supply Corp.accessdata.fda.gov
August 7, 1989K890763LABEL, STERILIZATION INDICATOR; DUAL STEAM/E.O.GASJOJSubstantially EquivalentSpsmedical Supply Corp.accessdata.fda.gov
August 7, 1989K890761STRIP, STERILIZATION INDICATOR; DRY HEATJOJSubstantially EquivalentSpsmedical Supply Corp.accessdata.fda.gov
August 7, 1989K890760STRIP, STERILIZATION INDICATOR, E.O. GASJOJSubstantially EquivalentSpsmedical Supply Corp.accessdata.fda.gov
August 7, 1989K890759STRIP, STERILIZATION INDICATOR; STEAMJOJSubstantially EquivalentSpsmedical Supply Corp.accessdata.fda.gov
August 7, 1989K890757C-VAPOR STERILIZATION INDICATOR, CHEMICAL VAPORJOJSubstantially EquivalentSpsmedical Supply Corp.accessdata.fda.gov
October 6, 1988K882756LANTOR CUBE STERILIZER TEST PACKJOJSubstantially EquivalentLantor Groupaccessdata.fda.gov
September 5, 1985K852170EZX YELLOW, BLUE OR ORANGEEGZSubstantially EquivalentStrong Marketingaccessdata.fda.gov

Compare with other makers

Updated January 21, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.