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FOLEY CATHETER INTRODUCER
 Request for Information Form |
 Contact Information
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| 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 | SU - General Plastic Surgery |
| FDA Product Code | GAH |
| FDA Classification Name | STYLET, SURGICAL, GENERAL & PLASTIC SURGERY |
| FDA Device Classification Code | General Controls |
| FDA Regulation Number | 878.4800 |
| FDA Common Generic Name | MANUAL SURGICAL INSTRUMENT FOR GENERAL USE |
| FDA Proprietary Device Name | FOLEY CATHETER INTRODUCER |
| 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, INC. 3773 CORPORATE PKWY. CENTER VALLEY, PA 18034 US 800-258-1946 / 610-984-9074 |
VARIOUS | VARIOUS |
| 2 | ALLGAIER INSTRUMENTE GMBH TEUCHELGRUBE 6-10 FRITTLINGEN, D-78665 GM 49-74-26 96 15-0 / 49-74-26 96 15-0 |
MULTIPLE | VARIOUS TYPES OF GENERAL & PLASTIC SURGERY STYLETS |
| 3 | BIOMET MICROFIXATION, INC. 1520 TRADEPORT DR. JACKSONVILLE, FL 32218 US 800-874-7711 / 904-741-9258 |
MULTIPLE | STYLET, SURGICAL, GENERAL & PLASTIC SURGERY |
| 4 | BLACKSTONE MEDICAL, INC. 90 BROOKDALE DR. SPRINGFIELD, MA 01104 US 413-731-8711 / 973-406-2838 |
STYLET | MANUAL SURGICAL INSTRUMENT FOR GENERAL USE |
| 5 | BLACKSTONE MEDICAL, INC. 1211 HAMBURG TURNPIKE SUITE 300 WAYNE, NJ 07470 US 413-731-8711 / 973-406-2838 |
STYLET | MANUAL SURGICAL INSTRUMENT FOR GENERAL USE |
| 6 | CARDINAL HEALTH GERMANY 206 GMBH KANTSTRASSE 33/1 TUTTLINGEN, D-78573 GM 847-689-8410 / 847-578-6442 |
MULTIPLE | MANUAL SURGICAL INSTRUMENT FOR GENERAL USE |
| 7 | CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES 1240 WAUKEGAN RD. MCGAW PARK, IL 60085 US 847-689-8410 / 847-578-6442 |
SURGICAL STYLET | VARIOUS |
| 8 | CODMAN & SHURTLEFF, INC. 325 PARAMOUNT DR. RAYNHAM, MA 02767 US 508-828-3704 / 508-828-3704 |
KARLIN WIRE STYLETTE | SURGICAL STYLET |
| 9 | CODMAN AND SHURTLEFF, INC. 50 SCOTLAND PARK DRIVE BRIDGEWATER, MA 02324 US 508-828-3704 / 508-828-3704 |
KARLIN WIRE STYLET | SURGICAL STYLET |
| 10 | COMBINED INSTRUMENTS (PVT.), LTD. 13-A MODEL TOWN, UGOKI SAILKOT, PK 04-32-510243 / 05-24-510243 |
STYLET, SURGICAL, GENERAL & PLASTIC SURGERY | SAME |
| 11 | CONMED LINVATEC BIOMATERIALS P.O. BOX 3 HERMIANKATU 6-8L TAMPERE, FIN-33720 FI 727-399-5234 / 727-399-5334 |
SMARTSCREW | STYLET |
| 12 | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 11 HAHOSHLIM ST. HERZLIYA, 46724 IS 972-9-9511511 / 972-9-9511511 |
MULTIPLE | VARIOUS TYPES OF STERILE STYLETS |
| 13 | DYNAMIC SURGICAL (PVT) LTD WAZIRABAD RD UGOKI SIALKOT, PK 92-52-3510268 / 92-52-3510268 |
STYLET SURGICAL GENERAL AND PLASTIC SURGERY | STYLET SURGICAL GENERAL AND PLASTIC SURGERY |
| 14 | EISENHUT INSTRUMENTE GMBH SCHILDECKSTR. 30 FRITTLINGEN, BADEN-WURTTEMBERG, D-78665 GM -49-7426-51990 / 011-49-7426-51990 |
MULTPLE | VARIOUS TYPES OF STYLETS |
| 15 | ELCON MEDICAL INSTRUMENTS GMBH DR. KARL-STORZ-STRASSE 26A TUTTLINGEN, D-78532 GM 074-61-9281-10 / 49-746-192810 |
STYLET, SURGICAL, GENERAL & PLASTIC SURGERY | STYLET, SURGICAL, GENERAL & PLASTIC SURGERY |
| 16 | FALCON SURGICAL CO (PVT) LTD. KHADIM ALI RD. P.O. BOX 134 SIALKOT, PUNJAB, 51310 PK 092-523-510072 / 043-2-553428 |
MULTIPLE | VARIOUS MODELS OF GENERAL & PLASTIC SURGERY SURGICAL STYLETS |
| 17 | FALCON SURGICAL CO (PVT) LTD. WAZIRABAD RD., P.O. BOX 134 NEAR VILLAGE GOLOPHALA UGOKI SIALKOT, PK 092-523-510072 / 720-962-5412 |
MULTIPLE | VARIOUS MODELS OF GENERAL & PLASTIC SURGERY SURGICAL STYLETS |
| 18 | GOGI & MOON MARALA RD., MURADPUR SIALKOT, PK 043-226-8811 |
STYLET, SURGICAL, GENERAL & PLASTIC SURGERY | STYLET, SURGICAL, GENERAL & PLASTIC SURGERY |
| 19 | ISPG, INC. 517 LITCHFIELD RD. NEW MILFORD, CT 06776 US 860-355-8511 / 860-355-8511 |
N/A | GROUND WIRE COMPONENTS |
| 20 | ISPG, INC. 816 BANTAM ROAD BANTAM, CT 06750 US 860-355-8511 / 860-355-8511 |
STYLET, SURGICAL, GENERAL & PLASTIC SURGERY | GROUND WIRE COMPONENTS |
| 21 | KARL STORZ GMBH & CO. KG MITTELSTRASSE 8 TUTTLINGEN, 78532 GM 49-74-617080 / 800-421-0837 4201 |
KARL STORZ SURGICAL STYLET | VARIOUS MODELS OF SURGICAL STYLETS |
| 22 | KAZAN MEDICAL INSTRUMENTS PLANT JOINT STOCK COMPAN 12, SAIDASHEV STREET KAZAN, TATARSTAN, 420022 RS / 713-723-6900 |
STYLET | STYLET |
| 23 | MANIKIN TRADERS KHADIM ALI RD. SIALKOT, 51310 PK 92-432-66995 / 92-432-66995 |
MULTIPLE | VARIOUS |
| 24 | MEDICAMAT S.A. 59, AVENUE AUGUSTIN DUMONT MALAKOFF, 92240 FR 331-46-56 24 04 / 303-530-3279 |
OMNIGRAFT AUTOMATED HAIR RESTORATION SYSTEM | SURGICAL STYLET |
| 25 | MEDICON, E.G. GAENSAECKER 15 TUTTLINGEN, D-78532 GM 49-746-220090 / 49-746-220090 |
STYLET, SURGICAL, GENERAL & PLASTIC SURGERY | STYLET |
| 26 | MEDTRONIC XOMED INSTRUMENTATION S.A.S. RUE LE PAVILLON SAINT AUBIN LE MONIAL BOURBON L'ARCHAMBAULT, 03160 FR 763-514-4000 / 904-279-7532 |
MICRO-FRANCE | MICRO-FRANCE |
| 27 | MICROSURGICAL LABORATORIES, INC. 11333 CHIMNEY ROCK RD., SUITE # 110-120 HOUSTON, TX 77035 US 713-723-6900 / 713-723-6900 |
PLASTIC SURGERY & GENERAL SURGICAL STYLET | PLASTIC SURGERY & GENERAL SURGICAL STYLET |
| 28 | MILTEX GMBH MUEHLSTRASSE 6 RIETHEIM- WEILHEIM, D-78604 GM 609-275-0500 / 717-840-3409 |
VARIOUS MODELS SURGICAL STYLETS FOR GENERAL AND PLASTIC SURG | VARIOUS MODELS SURGICAL STYLETS FOR GENERAL AND PLASTIC SURGERY |
| 29 | ORTHOVITA, INC. 45 GREAT VALLEY PKWY. MALVERN, PA 19355 US 610-640-1775 / 610-407-5246 |
ALIQUOT NEEDLE STYLET | NEEDLE STYLET |
| 30 | SMITH & NEPHEW INC., ENDOSCOPY DIV. 130 FORBES BLVD. MANSFIELD, MA 02048 US 978-749-1000 / 978-749-1073 |
CLEANING STYLETS | STYLET |
| 31 | SPECTRUM SCIENTIFIC, INC. 215 NORTH THIRD STREET GRAND HAVEN, MI 49417 US 248-880-0096 / 248-880-0096 |
MULTIPLE | HAIR TRANSPLANT MACHINE |
| 32 | STRYKER LEIBINGER GMBH & CO. KG BOTZINGER STRASSE 41 FREIBURG, D-79111 GM 269-385-2600 / 49-761-4512x185 |
MULTIPLE | VARIOUS TYPES OF STYLETS SURGICAL, GENERAL & PLASTIC SURGERY |
| 33 | SURGICON (PVT) LTD. P.O. BOX 244 KHADIM ALI RD. SIALKOT, PUNJAB, PK 92-432-262530 31 / 92-432-262531 32 |
STYLET SURGICAL GENERAL & PLASTIC SURGERY | STYLET SURGICAL GENERAL & PLASTIC SURGERY |
| 34 | SYNTHES (USA) 1230 WILSON DRIVE WEST CHESTER, PA 19380 US 610-719-5000 / 484-356-9728 |
MULTIPLE | VARIOUS STYLETS |
| 35 | SYNTHES TUTTLINGEN UNTER HASSLEN 5 TUTTLINGEN, 78532 GM / 484-356-9728 |
VARIOUS | VARIOUS |
| 36 | TELEFLEX MEDICAL 2917 WECK DR. RESEARCH TRIANGLE PARK, NC 27709 US 919-544-8000 / 919-433-4829 |
MULTIPLE GENERAL & PLASTIC SURGERY SURGICAL STYLETS | VARIOUS TYPES OF GENERAL/PLASTIC SURGERY SURGICAL STYLETS |
| 37 | TUMBOTINO, M.GORKY MEDICAL INSTRUMENT PLANT(MIZ) 1 PUSHKINA STR. TUMBOTINO, 606131 RS / 713-723-6900 |
STYLET, SURGICAL, GENERAL & PLASTIC SURGERY | SURGICAL STYLET FOR GENERAL & PLASTIC SURGERY |
| 38 | USTOMED INSTRUMENTE ULRICH STORZ GMBH & CO. KG AM EICHBUEHL 70-72 TUTTLINGEN, D-78532 GM 49-746-1965850 / 49-746-1965850 |
MULTIPLE | VARIOUS MODELS OF STYLETS FOR GENERAL AND PLASTIC SURGERY |
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