URODYNAMIC MEASUREMENT SYSTEM MANUFACTURED BY TELEFLEX MEDICAL

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Request for Information Form	Contact Information
Company Name	TELEFLEX MEDICAL
Address	AVE. INDUSTRIAS NO.5954 PARQUE INDUSTRIAL FINSA
City, State, Zip	NUEVO LAREDO, TAMAULIPAS,
Country	MX
FDA Owner/Operator Phone	919-544-8000
FDA Medical Specialty Code	GU - Gastroenterology/Urology
FDA Product Code	FAP
FDA Classification Name	CYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE
FDA Device Classification Code	Standards
FDA Regulation Number	876.1620
FDA Common Generic Name	URODYNAMIC RECTAL CATHETER
FDA Proprietary Device Name	URODYNAMIC MEASUREMENT SYSTEM
FDA Owner / Operator Number	9062981
FDA Owner / Operator Name	TELEFLEX MEDICAL
FDA Establishment Registration Number	3004365956
FDA Registered Establishment Name	TELEFLEX MEDICAL
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	03-14-05
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	ALPINE BIOMED APS 16-18 TONSBAKKEN SKOVLUNDE, DK-2740 DA 45-44-579000 / 45-44-579028	ST.MARKUS'S PUDENDAL ELECTRODE	URODYNAMICS MEASUREMENT SYSTEM
2	ANDROMEDA MEDIZINISCHE SYSTEME GMBH WALLBERGSTRASSE 5 TAUFKIRCHEN/POTZHAM, D-82024 GM 49-89-6141560 / 301-279-2899	ELLIPSE	URODYNAMIC SYSTEM
3	COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. SPENCER, IN 47460 US 812-829-4891 / 812-829-4891	MULTIPLE	VARIOUS TYPES AND SIZES OF STERILE AND NON-STERILE URODYNAMICS,URETHRAL PROFILOM
4	MEDTRONIC NEUROMODULATION 4000 LEXINGTON AVENUE SHOREVIEW, MN 55126 US 763-514-4000 / 763-505-0874	MULTIPLE	VARIOUS TYPES OF CYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICES
5	TELEFLEX MEDICAL 4024 STIRRUP CREEK DR. SUITE 720 DURHAM, NC 27703 US 919-544-8000 / 919-433-4829	MULTIPLE CYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE	VARIOUS CYSTOMETRIC GAS (CARBO-DIOXIDE) ON HYDRAULIC