Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006008984

FEI Number

3006008984

Entity Name

CROSSTEX INTERNATIONAL, INC.

City/State/Country

SHARON, PA, US

Establishment Address

534 VINE STREET, SHARON, PA 16146, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Crosstex International (Owner Number: 2433773)

Owner / Operator Contact Address

6789 WEST HENRIETTA RD., --, Rush, NY 14543, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K941327

PMA Number

N/A

All Registered Proprietary Names

Plastic Headrest Cover MaxVac Plus Combo Tip Combo-TIp Duo-Check Sterilization Pouches Sure-Check Sterilization Pouches

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2014-10-28
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2012-02-20
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	1995-10-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Crosstex International

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003675658	CROSSTEX INTERNATIONAL, INC.	LAWRENCEVILLE, GA, US

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006008984. Last updated year: 2026. Please use registration number 3006008984 when referencing this establishment in official correspondence.