UTERINE ACCESS DEVICE MANUFACTURED BY COOK UROLOGICAL, INC.

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UTERINE ACCESS DEVICE

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	KNA
FDA Classification Name	INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
FDA Device Classification Code	Standards
FDA Regulation Number	884.4530
FDA Common Generic Name	VARIOUS TYPES OF UTERINE ACCESS DEVICES
FDA Proprietary Device Name	UTERINE ACCESS DEVICE
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)	ME - Contract Manufacturer MM - Manufacturer MR - Remanufacturer MS - Specification Developer RR - Repackager/Relabeller
FDA Listing Date	04-14-06
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	AESCULAP AG & CO. KG. AM AESCULAP PLATZ TUTTLINGEN, DONAU, D-78532 GM 49-74-6195-1548 / 610-984-9074	VARIOUS	VARIOUS
2	AESCULAP, INC. 3773 CORPORATE PKWY. CENTER VALLEY, PA 18034 US 800-258-1946 / 610-984-9074	OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT	OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT
3	APPLE MEDICAL CORP. 28 LORD RD., UNIT 135 MARLBORO, MA 01752 US 508-357-2700 225 / 508-357-2700	MULTIPLE	VARIOUS HAND-HELD OB/GYN SURGICAL INSTRUMENTS
4	BIRCHWOOD LABORATORIES, INC. 7900 FULLER RD. EDEN PRAIRIE, MN 55344 US 952-937-7900 / 952-937-7956 7956	CYTETTE (R)	ENDOCERVICAL BRUSH
5	C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION 55 TECHNOLOGY DR. LOWELL, MA 01851 US 908-277-8000 / 908-277-8513	INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC	BARD UTERINE MANUPULATOR
6	CATHETER RESEARCH, INC. 5610 WEST 82ND ST. INDIANAPOLIS, IN 46278 US 317-872-0074 / 317-872-0074	INTERINE MANIPALATION/INJECTION INSTRUMENT	INTERINE MANIPALATION/INJECTION INSTRUMENT
7	CLINICAL INNOVATIONS, LLC 747 WEST 4170 SOUTH MURRAY, UT 84123 US 903-675-9321 / 801-268-8200	SOFTLIFT LAPAROTOMY VACUUM MANIPULATOR	INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
8	CONFLUENT SURGICAL,INC 101A FIRST AVE. WALTHAM, MA 02451 US 508-261-8587 / 203-492-5157	FLOWFIL ABSORBABLE INTRAUTERINE STENT	ABSORBABLE INTRAUTERINE STENT
9	COOK, INC. 750 DANIELS WAY PO BX 489 BLOOMINGTON, IN 47402 US 812-339-2235 / 812-339-2235	COOK HYSTEROCATH	HYSTEROCATH
10	COVIDIEN LP, FORMERLY REGISTERED AS LUDLOW TWO LUDLOW PARK DR. CHICOPEE, MA 01022 US 508-261-8587 / 508-261-8587	CLAMP OUT	UMBILICAL CLAMP AND CUTTER
11	GERHARD SURGICAL AND MEDICAL SUPPLY, INC. 1432 HANLEY INDUSTRIAL CT. BRENTWOOD, MO 63144 US 314-918-8877 / 314-918-8877		VARIOUS GYNECOLOGICAL INSTRUMENTS
12	HEALING SURGICAL CORP. NORGATE ST. SIALKOT, PUNJAB, 51310 PK 009-243-2580399 / 009-243-2580399	MULTIPLE	INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
13	HEALTH CARE LOGISTICS, INC. 3605 URBANCREST INDUSTRIAL DR. GROVE CITY, OH 43123 US 800-848-1633 / 800-848-1633	UMBILICAL CORD CLAMP & CUTTER	UMBILICAL CORD CLAMP & CUTTER
14	INMED MFG.SDN.BHD,RUSCH., TELEFLEX MEDICAL P.O. BOX 28, KAMUNTING INDUSTRIAL ESTATE, KAMUNTING PERAK, 34600 MY 919-544-8000 / 919-433-4829	MULTIPLE OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENTS	VARIOUS OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENTS
15	IN'TECH MEDICAL SAS 158 RUE DE L'EGLISE BP15 RANG DU FLIERS, 62180 FR 33-321-896000 / 757-224-0177	UNIGYN SINGLE USE MULTIPLE GRASPERS	DISPOSABLE GRASPER
16	PRICE INVENA APS KRONPRINSESSEGADE 36, 2. COPENHAGEN K, 1306 DA 45-33-691210 / 45-33-691210	SAFESTART (TM) CLAMP & CUTTER	UMBILICAL CORD CLAMP & CUTTER
17	RI MOS. S.R.L. VIALE GRAMSCI,N.29 MIRANDOLA (MO), IT 011-39-53525755 / 757-224-0177	AMNIOPER	AMNIOTOME
18	ROCKET MEDICAL PLC WEAR INDUSTRIAL ESTATE WASHINGTON TYNE AND WEAR, NE38 9BZ UK 044-191-4194488 / 44-191-4194488	VAGINAL SPECULUM	VAGINAL SPECULUM
19	STERILIS, INC. 17092 NEWHOPE ST. FOUNTAIN VALLEY, CA 92708 US 714-437-9801 / 714-437-9801	VAGINAL PORT	SPECULUM, VAGINAL
20	TELEFLEX MEDICAL 4024 STIRRUP CREEK DR. SUITE 720 DURHAM, NC 27703 US 919-544-8000 / 919-433-4829	MULTIPLE OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENTS	VARIOUS OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENTS
21	TELEFLEX MEDICAL 2917 WECK DR. RESEARCH TRIANGLE PARK, NC 27709 US 919-544-8000 / 919-433-4829	MULTIPLE OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENTS	VARIOUS OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENTS
22	TELEFLEX MEDICAL TUTTLINGEN GMBH GAENSAECKER 36 TUTTLINGEN, 78532 GM 919-544-8000 / 919-433-4829	MULTIPLE OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENTS	VARIOUS OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENTS
23	UTAH MEDICAL PRODUCTS, INC. 7043 SOUTH 300 WEST MIDVALE, UT 84047 US 801-566-1200 / 801-566-1200 4039	LUMIN LAPAROSCOPIC UTERINE MANIPULATOR INJECTOR	UTERINE MANIPULATOR
24	VINCENT MEDICAL (DONG GUAN) MFG. CO., LTD. QIAO LONG DISTRICT, TANG XIA TOWN DONG GUAN CITY, GUANG DONG, 523730 CH 852-236-55688 / 852-236-55688	MULTIPLE	UMBILICAL CLAMP AND CUTTER