MULTIPLE MANUFACTURED BY GE HEALTHCARE FINLAND OY

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Request for Information Form	Contact Information
Company Name	GE HEALTHCARE FINLAND OY
Address	KUORTANEENKATU 2
City, State, Zip	HELSINKI,
Country	FI
FDA Owner/Operator Phone	847-277-5002
FDA Medical Specialty Code	GU - Gastroenterology/Urology
FDA Product Code	EYC
FDA Classification Name	CATHETER, UPPER URINARY TRACT
FDA Device Classification Code	Standards
FDA Regulation Number	876.5130
FDA Common Generic Name	STERILE FOLEY CATHETER WITH TEMPERATURE PROBES
FDA Proprietary Device Name	MULTIPLE
FDA Owner / Operator Number	9912004
FDA Owner / Operator Name	GENERAL ELECTRIC CO.
FDA Establishment Registration Number	9610105
FDA Registered Establishment Name	GE HEALTHCARE FINLAND OY
FDA Operation Code(s)	MS - Specification Developer
FDA Listing Date	07-17-06
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	AESCULAP, INC. 3773 CORPORATE PKWY. CENTER VALLEY, PA 18034 US 800-258-1946 / 610-984-9074	VARIOUS	VARIOUS
2	BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. BRANCHBURG, NJ 08876 US 908-722-5000 / 908-722-5000	BIOSEARCH INTERMITTENT URINARY CATHETER	INTERMITTENT URINARY CATHETER
3	DEGANIA SILICONE, LTD. DEGANIA BET EMEK HAYARDEN, 15130 IS 972-46-755712 / 972- 46-755712	FOLEY CATHETER WITH TEMPERATURE SENSOR	TEMPERATURE SENSOR CATHETER
4	DEROYAL CIENTIFICA DE LATINOAMERICA SA GLOBAL PARK P.O. BOX 180-3006, 602 PARKWAY LA AURORA, HEREDIA, 146 CS 506-293-9898 / 865-938-7828 1325	VARIOUS FOLEY CATHETERS	VARIOUS FOLEY CATHETERS
5	DEROYAL SURGICAL - ROSE HILL 100 ROSE HILL INDUSTRIAL PARK ROSE HILL, VA 24281 US 865-938-7828 / 865-938-7828 1325	CATHETER, UPPER URINARY TRACT	CATHETER, UPPER URINARY TRACT
6	DEROYAL TECHNOLOGIES, INC. 1211 HWY. 33 SOUTH NEW TAZEWELL, TN 37825 US 865-938-7828 / 865-938-7828 1325	PREMIER SERIES FOLEY CATHETER,& SIGNATURE SERIES FOLEY CATHETER	FOLEY CATHETER W/TEMPERATURE SENSOR & URINARY DRAINAGE CATHETER W/TEMPERATURE SE