Crosstex International

FDA Device Registration & Listing · Rush, NY, US · Registration 1319130

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1319130
FEI Number
1319130
Entity Name
Crosstex International
City/State/Country
Rush, NY, US
Establishment Address
6789 WEST HENRIETTA RD., Rush, NY 14543, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
SPS/Crosstex International (Owner Number: 1319130)
Owner / Operator Contact Address
1666 E Touhy Ave, Des Plaines, IL 60018, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K041099
PMA Number
N/A

All Registered 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 Indicator, biological sterilization process 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EKF Instrument, Contouring, Matrix, Operative Dental Class 1 872.4565 2020-12-09
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2016-11-21
FYE Dress, Surgical General, Plastic Surgery Class 1 878.4040 2020-12-09
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2020-12-09
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2012-12-04
JRG Block, Heating Clinical Chemistry Class 1 862.2050 1988-07-11
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2020-12-09
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2007-11-27
KMT Tray, Fluoride, Disposable Dental Class 1 872.6870 2020-12-09
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2016-10-05
EFN Cotton, Roll Dental Class 1 872.6050 2020-12-09
FLG Cleaner, Ultrasonic, Medical Instrument General Hospital Class 1 880.6150 2020-12-09
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2022-02-17
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2007-11-27
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2020-12-09
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2014-12-08
EGS Handpiece, Contra- And Right-Angle Attachment, Dental Dental Class 1 872.4200 2020-12-09
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2007-11-27
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2007-11-27
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2020-12-09
EHZ Evacuator, Oral Cavity Dental Class 1 872.6640 2020-12-09
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2007-11-27
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-12-09
NRD Unit, Operative Dental, Accessories Dental Class 1 872.6640 2020-12-09
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2007-11-27
EGZ Holder, Film, X-Ray Dental Class 1 872.1905 2020-12-09
FXX Mask, Surgical General, Plastic Surgery Class 2 878.4040 2020-12-09
EIE Dam, Rubber Dental Class 1 872.6300 2020-10-09
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2007-11-27
ECB Unit, Syringe, Air And/Or Water Dental Class 1 872.4565 2020-12-09
KXF Applicator, Absorbent Tipped, Non-Sterile General Hospital Class 1 880.6025 2020-12-09
EIA Unit, Operative Dental Dental Class 1 872.6640 2020-12-09
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2007-11-27
LBH Varnish, Cavity Dental Class 2 872.3260 2020-12-09
NRU Chair, Dental, Without Operative Unit Dental Class 1 872.6250 2020-12-09
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2019-02-11
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2021-06-10
EFA Handpiece, Belt And/Or Gear Driven, Dental Dental Class 1 872.4200 2020-12-09
KYW Container, Liquid Medication, Graduated General Hospital Class 1 880.6430 2020-12-09
MSH Respirator, Surgical General, Plastic Surgery Class 2 878.4040 2021-05-26
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2019-08-14
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2007-11-27
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2013-12-10
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2007-11-27
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2007-11-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SPS/Crosstex International
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243425 Talladium España, SL Guided DAS Surgical Kit 2025-07-22
K213209 K1 Medical, LLC EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device 2021-12-28
K012105 Symmetry Medical, Inc. POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM 2002-08-02
K243317 Infinitum Eta, Ltd. NUVENTUS NV.C™ Surgical Cassette and Tray 2025-02-11
K112536 Covidien SONICISION STERILIZATION TRAY 2012-04-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2007 N/A 2
3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
Z-0008-2025 Young Dental Manufacturing I, LLC 1
BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1319130. Last updated year: 2026. Please use registration number 1319130 when referencing this establishment in official correspondence.
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