BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Crosstex International

    Reg #: 1319130 · FEI: 1319130 · Expires 2026
    View on FDA
    Products
    33
    Proprietary Names
    108
    Establishment Types
    4
    Classifications
    33

    Registration Details

    Registration Name
    Crosstex International
    Registration Number
    1319130
    FEI Number
    1319130
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    6789 WEST HENRIETTA RD.
    City
    Rush
    State
    NY
    ZIP
    14543
    Country
    US

    Regulatory Submissions

    510(k) Number
    K882756

    Owner / Operator

    Firm Name
    SPS/Crosstex International
    Operator Number
    1319130
    Address
    1666 E Touhy Ave
    City
    Des Plaines
    State
    IL
    Postal Code
    60018
    Country
    US

    Products

    Device Name Product Code
    Instrument, Contouring, Matrix, Operative EKF
    Indicator, Physical/Chemical Sterilization Process JOJ
    Dress, Surgical FYE
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Indicator, Biological Sterilization Process FRC
    Block, Heating JRG
    Mask, Surgical FXX
    Tray, Fluoride, Disposable KMT
    Cotton, Roll EFN
    Cleaner, Ultrasonic, Medical Instrument FLG
    Bedding, Disposable, Medical KME
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Gauze / Sponge,Nonresorbable For External Use NAB
    Evacuator, Oral Cavity EHZ
    Unit, Operative Dental, Accessories NRD
    Holder, Film, X-Ray EGZ
    Dam, Rubber EIE
    Unit, Syringe, Air And/Or Water ECB
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Unit, Operative Dental EIA
    Varnish, Cavity LBH
    Chair, Dental, Without Operative Unit NRU
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Handpiece, Belt And/Or Gear Driven, Dental EFA
    Container, Liquid Medication, Graduated KYW
    Respirator, Surgical MSH
    Depressor, Tongue, Non-Surgical FMA
    Disinfectant, Medical Devices LRJ
    Paper, Articulation EFH
    Sterilant, Medical Devices MED
    Mouthpiece, Saliva Ejector DYN
    Absorber, Saliva, Paper KHR
    Wrap, Sterilization FRG

    Proprietary Names

    Matrix Strips Face Shield Sterilization Pouches & Wraps SporView Steam Self-Contained Biological Indicator, SCS-025, SCS-100 SporView@ Steam Self-Contained Biological Indicator, SCS-100 (Private labels BI-038, 6005500522) Crosstex Isofluid Fog Free Face Mask Crosstex Ultra Fluid Resistant No Fog Mask with Visor Crosstex Isofluid Fog Free Face Mask with Splash Visor Crosstex Procedural Earloop Face Mask Crosstex Ultra Fluid Resistant No Fog Earloop Face Mask Crosstex Isofluid Earloop Face Mask Crosstex Ultra Earloop Face Mask Criterion Sen. Skin Earloop Mask L3 Criterion Fitted Earloop Mask L3 Indicator, biological sterilization process ZAP Dual Arch Fluoride Gel Trays Cotton Rolls- Premium Cotton Rolls- Advantage Plus SaniProzyme General Purpose Non-Ammoniated Ultrasonic Cleaner Tartar and Stain Remover Crosszyme EfferZyme Effervescent Cleaning Tablets Crosstex VH2O2 Chemical Indicators Non-Woven Headrest Cover Polycoated Headrest Cover Plastic Headrest Cover Sparkle EZ Contra Angle Twist Plus Sparkle Prophy Angle Ultra Gauze Non-Woven Non-Woven Premium Non-woven Advantage Ultra Pure Non-Woven Non-Woven Advantage Plus Cotton Filled Sponges- Premium Non-Sterile, Advantage Plus Non-Sterile, Sterile All-Gauze Sponges Premium Evacuator Tips (HVE and MaxVac Plus Combo Tip) Surgical Aspirator Tips Sure-Check Strips Sani-Vac Evacuation System Cleaner Sensor Slip-Ease Edge Ease Bitewing Ease Sensor Slippers It's-A-Wrap Wrap Ease Crosstex Surgical Masks Dental Dam, Latex, Powder Free/Low Protein Dental dam, Non-Latex Air/Water Syringe Tips Patient's Choice Sparkle Premium Cotton Tipped Applicators DentaPure DP40 Cartridge Sparkle V Varnish Barrier Film Digital Sensor Sleeves Nylon Self Seal Sterilization Pouch Sparkle™ FREE Prophy Paste with Xylitol Sparkle™ Prophy Paste with Xylitol Prophy Paste TWIST RECIPROCATING D Medicine/Mixing Cups Crosstex Isolator Duckbill Surgical N95 Respirator Crosstex Isolator Molded Surgical N95 Respirator Crosstex Lead-free Steam Indicator Tape, STLF24MMBULK Hu-Friedy Lead-free Steam Indicator Tape, IMS-1461 (Private Labelled) Crosstex Lead-free Steam Indicator Tape, BTLF18MM Crosstex Lead-free Steam Indicator Tape, BTLF24MM Crosstex Lead-free Steam Indicator Tape, STLF18MMBULK DUAL Dot label, 10 bx/cs Aesculap EO Gas dot 3/8", 10,000/RL (FAX) DUAL Expiration label, 10 bx/cs Steam/Gas indicator label, 1000/rl, 10 rl/cs Raven, ProTest Vial Label, 2000/rl Aesculap, Paper Label Stock-continuous roll, 450 LF/rl CI STEN DUAL indicator label 5000/rl 1/2" DUAL dot, 2000/rl EO Gas Indicator Label, 1000/rl, 10 rl/cs Raven, Prospore2 Vial Label, 4000/rl Tongue Depressors Liquid Ultra Solution Standard Articulating Paper Precisely True Horse Shoe Isofluid Plus Surgical Masks Sani Glut Glutaraldehyde 3% Saliva Ejectors Premium In-Office Biological Monitoring System; C10SKPREM Basic In-Office Biological Monitoring System; C10SKBASIC Ultragard Professional Thrift Professional Regular Advantage Plus Econoback Advantage Polyback Contour Bib Sani-Tab Chain-Free Polyback Polygard Proback Polyback Sani-Tab Chain-Free Econoback Polygard Deluxe Patient Barrier Apron DentaPure DP365 Cartridge Sterilization Wrap Le Petit Masque Surgical Tie-On Mask

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device