UNI-COR BIOPSY NEEDLE, GASTROENTEROLOGY-UROLOGY DEVICES & BIOPSY INSTRUMENTS MANUFACTURED BY COOK UROLOGICAL, INC.

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UNI-COR BIOPSY NEEDLE, GASTROENTEROLOGY-UROLOGY DEVICES & BIOPSY INSTRUMENTS

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	GU - Gastroenterology/Urology
FDA Product Code	KNW
FDA Classification Name	INSTRUMENT, BIOPSY
FDA Device Classification Code	Standards
FDA Regulation Number	876.1075
FDA Common Generic Name	BIOPSY NEEDLES, PROSTATIC ASPIRATOIN BIOPSY SET, QUICK CORE (R) BIOPSY NEEDLES
FDA Proprietary Device Name	UNI-COR BIOPSY NEEDLE, GASTROENTEROLOGY-UROLOGY DEVICES & BIOPSY INSTRUMENTS
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	ABBOTT SPINE, INC. 12708 RIATA VISTA CIRCLE SUITE B-100 AUSTIN, TX 78727 US 847-937-6100 / 512-533-1038	ABBOTT SPINE, INC. SPINNAKER SYSTEM	VERTEBRAL BODY BIOPSY NEEDLE
2	ACUEITY, INC. 100 HAMILTON AVE., SUITE 140 PALO ALTO, CA 94301 US 650-473-9910 / 650-759-6186	EXCISOR BIOPTOME AND PRODUCT FAMILY	BREAST BIOPSY INSTRUMENT
3	ANGIOMED GMBH & CO. MEDIZINTECHNIK KG WACHHAUSSTRASSE 6 KARLSRUHE, 76227 GM 908-277-8000 / 908-277-8513	VACORA,MAXCORE,MONOPTY,MAGNUM,BIOPTY,TRUGUIDE,DUALOK,VACUCUT,BONOPTY,OSTYCUT	BIOPSY DEVICES AND ACCESSORIES
4	ARTHROCARE CORP. 680 VAQUEROS AVE. SUNNYVALE, CA 94085 US 408-736-0224 / 408-736-0224	MULTIPLE	BIOPSY INSTRUMENT
5	ASCENDIA MEDTECH AB FINLANDSGATAN 18 KISTA, SE 16474 SW 46-8-4445400 / 845-469-4289	BIOPSY GUN, FULLCORE	BIOPSY GUN
6	AVANTIS MEDICAL SYSTEMS, INC. 263 SANTA ANA CT. SUNNYVALE, CA 94085 US 408-733-1901 / 408-733-1901 227	THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM	ENDOSCOPE
7	BACHER RALPH MEDIZINTECHNIK GMBH LESSINGSTR. 46 TUTTLINGEN, D-78532 GM 074-61-6769 / 074-61-6769	MULTIPLE	VARIOUS
8	BARD PERIPHERAL VASCULAR, INC. 1625 WEST 3RD ST. P.O. BOX 1740 TEMPE, AZ 85280 US 908-277-8000 / 908-277-8513	VACORA,MAXCORE,MONOPTY,MAGNUM,BIOPTY-CUT	GASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT
9	BARD REYNOSA S.A. DE C.V. BLVD. MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL REYNOSA, TAMAULIPAS, MX 908-277-8000 / 908-277-8513	VACORA,MAXCORE,MONOPTY,MAGNUM,BIOPTY,MULTIPLE	BIOPSY DEVICES AND ACCESSORIES
10	BARD SHANNON LIMITED SAN GERONIMO INDUSTRIAL PARK LOT # 1, ROAD # 3, KM 79.7 HUMACAO, PR 00791 US 908-277-8000 / 908-277-8513	VACORA,MAXCORE,MONOPTY,MAGNUM,MULTIPLE	BIOPSY SYSTEMS
11	BIOMEDICAL SRL VIA G.B. LULLI FIRENZE, 43-50144 IT / 919-460-2535	BIOMEDICAL BONE BIOPSY NEEDLE	BONE MARROW BIOPSY NEEDLE
12	BIOMEDIZINISCHE-INSTRUMENTE & PRODUKTE,GMBH(BIP) AM BRAND 1 TUERKENFELD,BAVARIA, D-82299 GM 498-193-93180 / 498-193-93180	VACUFLASH BIOPSY SYSTEM	BIOPSY INSTRUMENT
13	BIOMET MICROFIXATION, INC. 1520 TRADEPORT DR. JACKSONVILLE, FL 32218 US 800-874-7711 / 904-741-9258	MULTIPLE	BIOPSY INSTRUMENTS
14	BIOMNI MEDICAL SYSTEMS, INC. 160 SOUTH 1350 EAST LEHI, UT 84043 US 801-768-0166 / 801-768-0166	SELECTACUT	BIOPSY GUN
15	BIOPSYBELL S.R.L. VIA LEA CAZZVOLI 14/16 S. GIACOMO RONCOLE MIRANDOLA (MO), 41037 IT 39-053-527850 / 973-575-0614	OSTEOBELL	BONE MARROW BIOPSY NEEDLE
16	BOSTON SCIENTIFIC CORPORATION 780 BROOKSIDE DRIVE SPENCER, IN 47460 US 508-652-5594 / 508-652-5594	MULTIPLE	VARIOUS
17	BUSSE HOSPITAL DISPOSABLES, INC. 75 ARKAY DR. HAUPPAUGE, NY 11788 US 631-435-4711 / 631-435-4711 254	BUSSE HOSPITAL DISPOSABLES BONE MARROW BIOPSY TRAY & J-STYLE NEEDLES	BONE MARROW BIOPSY TRAY AND J-STYLE NEEDLES
18	C.R. BARD, INC. 8195 INDUSTRIAL BLVD. COVINGTON, GA 30014 US 908-277-8000 / 908-277-8513	VACORA,MAXCORE,MONOPTY,MAGNUM,BIOPTY,TRUGUIDE,DUALOK,VACUCUT,BONOPTY,OSTYCUT	BIOPSY DEVICES AND ACCESSORIES
19	C.R. BARD, INC. 1211 MARY MAGNAN BLVD. MADISON, GA 30650 US 908-277-8000 / 908-277-8513	BIOPTY-CUT, MAX-CORE, MONOPTY, VACORA, MULTIPLE	BIOPSY INSTRUMENTS AND ACCESSORIES
20	CARDINAL HEALTH 400 EAST FOSTER RD. MANNFORD, OK 74044 US 847-689-8410 / 847-578-6610	MULTIPLE	VARIOUS TYPES OF BIOPSY NEEDLES AND DEVICES
21	CARDINAL HEALTH RD 203 LTD., ZONA FRANCA LAS AMERI AUT. LAS AMERICAS, KM 22 E-1 SANTO DOMINGO, DR 847-689-8410 / 847-578-6612	JAMSHIDI BONE MARROW & DISPOSABLE BONE MARROW BIOPSY NEEDLES & TRAYS	VARIOUS TYPES OF REUSABLE & DISPOSABLE BONE MARROW BIOPSY NEEDLES & TRAYS
22	COOK, INC. 750 DANIELS WAY PO BX 489 BLOOMINGTON, IN 47402 US 812-339-2235 / 812-339-2235	STANFORD BIOPSY SET	STERILE STANFORD BIOPSY SET
23	COVIDIEN LP, FORMERLY REGISTERED AS KENDALL 15 HAMPSHIRE ST. MANSFIELD, MA 02048 US 508-261-8587 / 508-261-8587	VARIOUS	VARIOUS SIZES AND STYLES OF BIOPSY NEEDLES
24	COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES 150 GLOVER AVE. NORWALK, CT 06856 US 508-261-8587 / 203-492-5157	AUTO SUTURE ABBI (ADVANCED BREAST BIOPSY INSTRUMENTATION) SYSTEM AND ACCESSORIES	BIOPSY INSTRUMENT
25	COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES 60 MIDDLETOWN AVENUE NORTH HAVEN, CT 06473 US 508-261-8587 / 203-492-5157	MIBB SITE MARKER	BIOPSY SITE MARKER
26	CYTYC CORP. 250 CAMPUS DRIVE MARLBOROUGH, MA 01752 US 508-263-2900 / 508-263-8851	FIRSTCYTE EZ MICROCATHETER AND ASPIRATOR	GASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT
27	DUFNER INSTRUMENTE GMBH FOEHRENSTR. 9 TUTTLINGEN, 78532 GM 011-49-74613697 / 011-493-74613697	BIOPSY INSTRUMENTS	SAME
28	ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. CINCINNATI, OH 45242 US 513-337-7000 / 513-337-3134	MAMMOTOME	VARIOUS TYPES OF STERILE AND NON STERILE BIOPSY INSTRUMENT
29	ETHICON ENDO-SURGERY, INC. 3801 UNIVERSITY BLVD., S.E. ALBUQUERQUE, NM 87106 US 513-337-7000 / 513-337-3134	MAMMOTOME	VARIOUS TYPES OF STERILE AND NON STERILE BIOPSY INSTRUMENT
30	ETHICON ENDO-SURGERY, INC. S.A. DE C.V. AVE. DELAS TORRES #7125 COL. SALVARCAR 118 CUIDAD JUAREZ, MX 513-337-7000 / 513-337-3134	MAMMOTOME	VARIOUS TYPES OF STERILE AND NON STERILE BIOPSY INSTRUMENT
31	ETHICON ENDO-SURGERY, LLC 475 CALLE C GUAYNABO, PR 00969 US 787-653-4608 / 513-337-3134	MAMMOTOME	INSTRUMENT,BIOPSY
32	GALLINI S.R.L. VIA SAN FAUSTINO 88, MIRANDOLA (MO), 41037 IT 39-535-21983 / 616-241-9987 22	GALLINI ABS BIOPSY GUN	BIOPSY INSTRUMENT
33	H.S HOSPITAL SERVICE S.P.A. VIA DELLE VALLI SNC APRILIA (LT) ITALIA, 04011 IT 39-6-910296 / 561-443-3321	BMN "I" BONE MARROW ASPIRATION NEEDLE	BONE MARROW ASPIRATION NEEDLE
34	HANS HERMANN GMBH WUERTTEMBERGER STRASSE 26 FRIDINGEN, 78567 GM 49-746-399670 / 49-746-39967 X35	INSTRUMENT, BIOPSY	BIOPSY
35	INTACT MEDICAL CORPORATION ONE APPLE HILL SUITE 316 NATICK, MA 01760 US 508-655-7820 146 / 508-655-7820 146	INTACT BREAST LESION EXCISION SYSTEM(BLES)	BIOPSY SYSTEM
36	INVIVO GERMANY GMBH HAGENOWER STR. 73 SCHWERIN, 19061 GM 49-385-3993 109 / 49-385-3993-109	MULTIPLE	VARIOUS
37	KS CNC U. LASERTECHNIK E.K. HAUPTSTRASSE 28 KOLBINGEN, D-78600 GM 074-637-525 / 011- 49-74637525	BIOPSY FORCEPS, GASTROENTEROLOGY-UROLOGY	BIOPSY FORCEPS, GASTROENTEROLOGY AND UROLOGY
38	LASER-OPTIK-SYSTEME GMBH & CO. KG LANGGASSE 90 HOHENSTEIN, 65329 GM 061-205-533 / 49-61-2092170	3D VISION 100	3D-ENDOSCOPY-SYSTEM
39	MANAN MEDICAL PRODUCTS, INC. 241 WEST PALATINE RD. WHEELING, IL 60090 US 604-221-7676 / 224-625-8610	BIOPSY NEEDLE	BIOPSY NEEDLE
40	MEDICAL DEVICE TECHNOLOGIES, INC. 3600 S.W. 47TH AVE. GAINESVILLE, FL 32608 US 604-221-7676 / 352-338-0440 350	MULTIPLE	VARIOUS MODELS OF BIOPSY NEEDLES, STERILE
41	MEDSOL CORP. 157 EAST 32ND ST., 2 FL. NEW YORK, NY 10016 US 800-272-6322 119 / 212-689-6791	MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE	BONE MARROW BIOPSY NEEDLE
42	MICRO ENGINEERING CO. MUZAFFAR PUR, UGOKI ROAD SIALKOT, PUNJAB, 51310 PK 92-52-3563928-48 / 92-52-3563928-48	TAMSCO	KEVORKIAN-YOUNGE BIOPSY FORCEPS
43	MINRAD, INC. 50 COBHAM DR. ORCHARD PARK, NY 14127 US 716-855-1068 / 716-855-1068	LIGHT SABER	CORE TISSUE BIOPSY NEEDLE
44	NEOMATRIX, LLC 16 TECHNOLOGY DR. SUITE 118 IRVINE, CA 92618 US 949-753-7844 / 949-753-7844	HALO NAF COLLECTION SYSTEM	BREAST ASPIRATOR
45	ORTHOVITA, INC. 45 GREAT VALLEY PKWY. MALVERN, PA 19355 US 610-640-1775 / 610-407-5246	IMBIBE BONE MARROW ASPIRATION NEEDLE	BONE MARROW ASPIRATION NEEDLE
46	PAJUNK GMBH MEDIZINTECHNOLOGIE KARL-HALL-STRASSE 01 GEISINGEN, BADEN-WURTTEMBERG, 78187 GM 49-770-4 9291 0 / 49-770-492910 533	CHIBA, SPECIAL SPROTTE, CHIBA SPECIAL	CANNULAS/ NEEDLES FOR BIOPSY, PUNCTURE, ASPIRATION
47	PNEUMRX, INC. 530 LOGUE AVENUE MOUNTAIN VIEW, CA 94043 US 650-625-8910 / 650-625-8910 107	SEEKER STEERABLE BIOPSY NEEDLE SYSTEM (TM) (FAMILY OF)	STERILE AND NON-STERILE INSTRUMENT, BIOPSY
48	PROMEX TECHNOLOGIES, LLC 3049 HUDSON ST. FRANKLIN, IN 46131 US 317-736-0128 / 317-736-0128	MANUAL BONE MARROW BIOPSY DEVICE, BONE BIOPSY NEEDLE, TROCAR, INTRODUCER NEEDLE,	MANUAL BONE MARROW BIOPSY DEVICE, BONE BIOPSY NEEDLE, TROCAR, INTRODUCER NEEDLE,
49	RANFAC CORP. 30 DOHERTY AVE., P.O. BOX 635 AVON INDUSTRIAL PARK AVON, MA 02322 US 508-588-4400 / 508-588-4400 121	"1" TYPE BONE MARROW ASPIRATION NEEDLE	BONE MARROW BIOPSY NEEDLE
50	REMINGTON MEDICAL, INC. 6830 MEADOWRIDGE CT. ALPHARETTA, GA 30005 US 770-888-8520 / 770-888-8520	NAC REMINGTON AUTOMATIC CUTTING NEEDLE	AUTOMATIC CUTTING NEEDLE
51	RUBICOR MEDICAL, INC. 600 CHESAPEAKE DRIVE REDWOOD CITY, CA 94063 US 650-556-1070 32 / 650-587-3446	RUBICOR BREAST BIOPSY DEVICE	BIOPSY INSTRUMENT
52	RZ MEDIZINTECHNIK GMBH UNTER HASSLEN 20 TUTTLINGEN, 78532 GM 49-746-294700 / 49-746-294700	BIOPSY INSTRUMENT	BIOPSY INSTRUMENT
53	SANARUS MEDICAL, INC. 4696 WILLOW RD. PLEASANTON, CA 94588 US 925-460-5730 / 925-460-5730	CENTRICA	CORE TISSUE BIOPSY SYSTEM
54	SENORX, INC. 11 COLUMBIA ALISO VIEJO, CA 92656 US 949-362-4800 / 949-362-4800	ANCHOR GUIDE TM	LESION LOCALIZTION DEVICE-STERILE
55	SITESELECT MEDICAL TECHNOLOGIES, LTD 1210 W. EXPRESSWAY 83, #10 PHARR, TX 78577 US 956-787-6651 / 956-787-6651	SITESELECT BREAST BIOPSY DEVICES	BIOPSY INSTRUMENTS/DEVICES
56	STERYLAB USA, LLC 2916 GRAHAM RD., SUITE C FRANKLIN, IN 46131 US 390-293-508427 / 317-847-0264	GASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT	BIOPSY INSTRUMENT
57	STRYKER INTERVENTIONAL PAIN 4664 CAMPUS DR. SUITE 130 KALAMAZOO, MI 49008 US 269-385-2600 / 269-323-7700 3388	STRYKER VERTEBRAL BIOPSY NEEDLES	BIOPSY NEEDLES
58	STRYKER PUERTO RICO, LTD. HWY. 3, KM. 131.2 LAS GUASIMAS IND. PARK ARROYO, PR 00714 US 269-385-2600 / 939-307-2606	STRYKER VERTEBRAL BIOPSY NEEDLES	BIOPSY NEEDLES
59	SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY 6100,6110,6120 TECHNOLOGY CTR DRIVE INDIANAPOLIS, IN 46278 US 781-999-7300 / 317-344-7630	INSTRUMENT,BIOPSY	VACUUM ASSISTED CORE BIOPSY DEVICE
60	TINOPAL SURGICAL CORP. (PVT), LTD. UNIT #1, 55/57-B. SMALL INDUSTRIES ESTATE SIALKOT, PUNJAB, 51311 PK 92-52-3255454 / 92-52-3552298	INSTRUMENT, BIOPSY	INSTRUMENT, BIOPSY
61	TUMED SURGICAL INSTRUMENTS & HOSPITAL SUPPLIES GMB ROTWILDSTR. 20 - 22 TUTTLINGEN, 78532 GM 011-49-7461965880 / 011-49-7461965880	INSTRUMENT, BIOPSY (MULTIPLE BRANDS)	INSTRUMENT, BIOPSY
62	USSC PUERTO RICO, INC. BUILDING 911-67 SABANETAS INDUSTRIAL PARK PONCE, PR 00731 US 508-261-8587 / 203-492-5157	AUTO SUTURE ABBI (ADVANCED BREAST BIOPSY INSTRUMENTATION) SYSTEM AND ACCESSORIES	BIOPSY INSTRUMENT
63	WORLDWIDE MEDICAL TECHNOLOGIES, LLC 115 HURLEY ROAD OXFORD, CT 06478 US 203-262-4190 / 203-262-4190 105	WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOSPY NEEDLE	BONE MARROW BIOPSY NEEDLE