PREMIER SERIES FOLEY CATHETER,& SIGNATURE SERIES FOLEY CATHETER MANUFACTURED BY DEROYAL TECHNOLOGIES, INC.

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Request for Information Form	Contact Information
Company Name	DEROYAL TECHNOLOGIES, INC.
Address	1211 HWY. 33 SOUTH
City, State, Zip	NEW TAZEWELL, TN 37825
Country	US
FDA Owner/Operator Phone	865-938-7828
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	FOLEY CATHETER W/TEMPERATURE SENSOR & URINARY DRAINAGE CATHETER W/TEMPERATURE SE
FDA Proprietary Device Name	PREMIER SERIES FOLEY CATHETER,& SIGNATURE SERIES FOLEY CATHETER
FDA Owner / Operator Number	1044833
FDA Owner / Operator Name	DEROYAL INDUSTRIES, INC.
FDA Establishment Registration Number	1055236
FDA Registered Establishment Name	DEROYAL TECHNOLOGIES, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	06-29-94
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	GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 HELSINKI, FIN-00510 FI 847-277-5002 / 414-721-3945	MULTIPLE	STERILE FOLEY CATHETER WITH TEMPERATURE PROBES