CATHETER, UPPER URINARY TRACT MANUFACTURED BY DEROYAL SURGICAL

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Request for Information Form	Contact Information
Company Name	DEROYAL SURGICAL - ROSE HILL
Address	100 ROSE HILL INDUSTRIAL PARK
City, State, Zip	ROSE HILL, VA 24281
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	CATHETER, UPPER URINARY TRACT
FDA Proprietary Device Name	CATHETER, UPPER URINARY TRACT
FDA Owner / Operator Number	1044833
FDA Owner / Operator Name	DEROYAL INDUSTRIES, INC.
FDA Establishment Registration Number	1046367
FDA Registered Establishment Name	DEROYAL SURGICAL - ROSE HILL
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer MS - Specification Developer RR - Repackager/Relabeller
FDA Listing Date	11-16-00
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 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