FOLEY CATHETER WITH TEMPERATURE SENSOR MANUFACTURED BY DEGANIA SILICONE, LTD.

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Request for Information Form	Contact Information
Company Name	DEGANIA SILICONE, LTD.
Address	DEGANIA BET
City, State, Zip	EMEK HAYARDEN,
Country	IS
FDA Owner/Operator Phone	972-46-755712
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	TEMPERATURE SENSOR CATHETER
FDA Proprietary Device Name	FOLEY CATHETER WITH TEMPERATURE SENSOR
FDA Owner / Operator Number	8030107
FDA Owner / Operator Name	DEGANIA SILICONE, LTD.
FDA Establishment Registration Number	8030107
FDA Registered Establishment Name	DEGANIA SILICONE, LTD.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	07-30-06
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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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	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
4	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
5	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
6	GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 HELSINKI, FIN-00510 FI 847-277-5002 / 414-721-3945	MULTIPLE	STERILE FOLEY CATHETER WITH TEMPERATURE PROBES