CYBILNATE MANUFACTURED BY MEDSTENT, DIVISION OF DORMER LABORATORIES INC.

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Request for Information Form	Contact Information
Company Name	MEDSTENT, DIVISION OF DORMER LABORATORIES INC.
Address	91 KELFIELD RD., UNIT 5
City, State, Zip	TORONTO, ONTARIO,
Country	CA
FDA Owner/Operator Phone	416-242-6167
FDA Medical Specialty Code	HO - General Hospital
FDA Product Code	FOS
FDA Classification Name	CATHETER, UMBILICAL ARTERY
FDA Device Classification Code	Standards
FDA Regulation Number	880.5200
FDA Common Generic Name	UMBILICAL VESSEL CATHETER
FDA Proprietary Device Name	CYBILNATE
FDA Owner / Operator Number	9009928
FDA Owner / Operator Name	MEDSTENT, DIVISION OF DORMER LABORATORIES INC.
FDA Establishment Registration Number	3002658593
FDA Registered Establishment Name	MEDSTENT, DIVISION OF DORMER LABORATORIES INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	01-01-94
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	COVIDIEN LP, FORMERLY REGISTERED AS KENDALL 130 SOUTH MAIN ST. ORISKANY FALLS, NY 13425 US 508-261-8587 / 508-261-8587	ARGYLE UMBILICAL ARTERY CATHETER	VARIOUS SIZES OF STERILE CATHETERS
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4	UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST MIDVALE, UT 84047 US 801-566-1200 / 801-566-1200 4039	UMBILI-CATH	UVC
5	VYGON CORP. 2495 GENERAL ARMISTEAD AVE NORRISTOWN, PA 19403 US 610-539-9300 / 610-539-9300 110	VYGON DOUBLE LUMEN UMBILICAL CATHETER	PEDIATRIC DOUBLE LUMEN UMBILICAL CATHETER
6	VYGON S A 5-11 RUE ADELINE ECOUEN 95440, FR / 610-539-9300	CATHETER, UMBILICAL ARTERY	UMBILICAL ARTERY CATHETER (STERILE)