ECHO-TIP NEEDLE MANUFACTURED BY COOK UROLOGICAL, INC.

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ECHO-TIP NEEDLE

Request for Information Form	Contact Information
Company Name	COOK UROLOGICAL, INC.
Address	1100 WEST MORGAN ST.
City, State, Zip	SPENCER, IN 47460
Country	US
FDA Owner/Operator Phone	812-829-4891
FDA Medical Specialty Code	OB - Obstetrics/Gynecology
FDA Product Code	HIO
FDA Classification Name	SAMPLER, AMNIOTIC FLUID (AMNIOCENTESIS TRAY)
FDA Device Classification Code	General Controls
FDA Regulation Number	884.1550
FDA Common Generic Name	AMNIOCENTESIS NEEDLE
FDA Proprietary Device Name	ECHO-TIP NEEDLE
FDA Owner / Operator Number	1825146
FDA Owner / Operator Name	COOK UROLOGICAL, INC.
FDA Establishment Registration Number	1825146
FDA Registered Establishment Name	COOK UROLOGICAL, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	12-31-92
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of COOK UROLOGICAL, INC.

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	ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	AMNIOCENTESIS TRAY	AMNIOCENTESIS TRAY
2	BUSSE HOSPITAL DISPOSABLES, INC. 75 ARKAY DR. HAUPPAUGE, NY 11788 US 631-435-4711 / 631-435-4711 254	BUSSE HOSPITAL DISPOSABLES AMNIOCENTESIS TRAY	AMNIOCENTESIS TRAY
3	CARDINAL HEALTH 400 EAST FOSTER RD. MANNFORD, OK 74044 US 847-689-8410 / 847-578-6610	SAMPLER, AMNIOTIC FLUID (AMNIOCENTESIS TRAY)#OBSTETRICS AND GYNECOLOGY	VARIOUS AMNIOCENTESIS NEEDLES & TRAYS
4	CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES 1430 WAUKEGAN RD. MCGAW PARK, IL 60085 US 847-689-8410 / 847-578-6442	MULTIPLE	VARIOUS AMNIOCENTESIS NEEDLES AND TRAYS
5	CYTYC CORPORATION 1240 ELKO DRIVE SUNNYVALE, CA 94089 US 508-263-2900 / 508-263-8851	ADEZA BIOMEDICAL SPECIMEN COLLECTION KIT	SPECIMEN COLLECTION KIT
6	ERCHINGER CHIRURGISCHE INSTRUMENTE RUDOLF-DIESEL-STRASSE 20 TUTTLINGEN, D-78532 GM / 011-49-7461966250	MULTIPLE	AMNIOTIC FLUID SAMPLERS
7	E-Z-EM, INC. 750 SUMMA AVE. WESTBURY, NY 11590 US 800-544-4624 3407 / 516-333-8230 3407	PERCUSET PROCEDURE TRAYS	STERILE PROCEDURE TRAYS FOR VARIOUS PERCUTANEOUS PROCEDURES
8	GALLINI S.R.L. VIA SAN FAUSTINO 88, MIRANDOLA (MO), 41037 IT 39-535-21983 / 616-241-9987 22	AMNIOCETESIS KIT	AMNIOCETESIS KIT
9	KEAN YIH ENTERPRISE CO., LTD. 1F., NO. 8-3, TING PEI SHIAH PEI LI, W. DIST. CHIAYI HSIEN, TW 886-5-3416398 / 815-385-0100	VARIOUS	AMNIOTIC MEMBRANE PERFORATOR
10	MD NEXELL MEDICAL LA ESTANCIA INDUSTRIAL, KM 9 AVE PRINICIPAL FINAL GALPON 19 FILAS DE MARICHE, EDO MIRANDA, 1070 VE 582-12--963-6433 / 305-859-7632	MD AMNIOCENTESIS TRAY	AMNIOCENTESIS TRAY
11	MEDICAL WIRE AND EQUIPMENT CO. LTD. POTLEY CORSHAM, WILTSHIRE, SN13 9RT UK 44-122-5 810361 / 44-122-5 810153	AMNICATOR	AMNICATOR FLUID INDICATOR
12	NORTH COAST MEDI-TEK 8603 EAST AVE. MENTOR, OH 44060 US 440-974-0750 / 440-974-0750	APT-1	AMNIOCENTESIS TRAY
13	PRO-LAB, INC. 20 MURAL ST., #4 RICHMOND HILL, ONTARIO, L4B 1K3 CA 905-731-0300 / 905-731-0300	AMNIOTEST	SWAB TO AID IN DETECTION OF AMNIOTIC FLUID
14	SMITHS MEDICAL ASD, INC. 10 BOWMAN DR. KEENE, NH 03431 US 114-420-8-458-3232 / 603-352-3812 2457	MULTIPLE	VARIOUS TYPES OF STERILE AMNIOCENTESIS TRAYS
15	SMITHS MEDICAL INTERNATIONAL LTD. BOUNDIRY RD. HYTHE, KENT, CT 21 5BN UK 114-420-8-458-3232 / 44-130-3260551	WALLACE AMINOCENTESIS NEEDLE VARIOUS GAUGES	AMINOCENTESIS NEEDLE
16	SWEMED LAB INTERNATIONAL AB BILLDALSVAGEN 2 BILLDAL, SE-427 36 SW 46-31-7218000 / 46-31-7218076	NEEDLE FOR AMINOCENTESIS, NEEDLE FOR CYST PUNCTURE	NEEDLE FOR AMINOCENTESIS, NEEDLE FOR CYST PUNCTURE