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OPTIFLO HEMOSTASIS CATHETER
 Request for Information Form |
 Contact Information
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| Company Name | ACCELLENT INC. |
| Address | 1526-6 CALLE HERTZ |
| City, State, Zip | JUAREZ, CHIHUAHUA, |
| Country | MX |
| FDA Owner/Operator Phone | 866-899-1392 |
| FDA Medical Specialty Code | GU - Gastroenterology/Urology |
| FDA Product Code | FBK |
| FDA Classification Name | ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 876.1500 |
| FDA Common Generic Name | INJECTION NEEDLE |
| FDA Proprietary Device Name | OPTIFLO HEMOSTASIS CATHETER |
| FDA Owner / Operator Number | 9048369 |
| FDA Owner / Operator Name | ACCELLENT INC. |
| FDA Establishment Registration Number | 9680001 |
| FDA Registered Establishment Name | ACCELLENT INC. |
| FDA Operation Code(s) |
ME - Contract Manufacturer MM - Manufacturer MS - Specification Developer |
| FDA Listing Date | 09-07-06 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of ACCELLENT 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 | AOMORI OLYMPUS CO., LTD. 2-248-1, OKKONOKI KUROISHI-SHI, AOMORI-KEN, 036-0357 JA / 484-896-5688 |
MULTIPLE | VARIOUS TYPES OF ASPIRATION AND INJECTION NEEDLES |
| 2 | AVENT S.A. DE C.V. CARRETERA INTERNACIONAL SALIDA NORTE #1053 MAGDALENA, SONORA, CP 84160 MX 520-584-6021 / 770-587-8393 |
ENDOSCOPIC NEEDLE | ENDOSCOPIC NEEDLE |
| 3 | BALLARD MEDICAL PRODUCTS 12050 LONE PEAK PKWY. DRAPER, UT 84020 US 972-281-1200 / 770-587-8393 |
INJECTION NEEDLE CATHETER | INJECTION NEEDLE CATHETER |
| 4 | BOSTON SCIENTIFIC CORPORATION 780 BROOKSIDE DRIVE SPENCER, IN 47460 US 508-652-5594 / 508-652-5594 |
HEMOJECT | SCLEROTHERAPY NEEDLES |
| 5 | C.R. BARD, INC. 1211 MARY MAGNAN BLVD. MADISON, GA 30650 US 908-277-8000 / 908-277-8513 |
TEGRESS IMPLANT NEEDLE, TRANSURETHRAL FLEXIBLE IMPLANT NEEDLE | ENDOSCOPIC NEEDLES |
| 6 | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. COVINGTON, GA 30014 US 908-277-8000 / 908-277-8513 |
TEGRESS TRANSURETHRAL FLEXIBLE IMPLANT NEEDLE,TEGRESS TRANSURETHRAL STAINLESS ST | ENDOSCOPIC NEEDLE |
| 7 | CARBON MEDICAL TECHNOLOGIES, INC. 1290 HAMMOND RD. ST. PAUL, MN 55110 US 651-653-8512 / 651-762-2146 |
CMT ENDOSCOPIC INJECTION NEEDLE | INJECTION NEEDLE |
| 8 | COMBINED INSTRUMENTS (PVT.), LTD. 13-A MODEL TOWN, UGOKI SAILKOT, PK 04-32-510243 / 05-24-510243 |
NEEDLE, ENDOSCOPIC | SAME |
| 9 | DYNAMIC SURGICAL (PVT) LTD WAZIRABAD RD UGOKI SIALKOT, PK 92-52-3510268 / 92-52-3510268 |
NEEDLE ENDOSCOPEC | NEEDLE ENDOSCOPEC |
| 10 | ENDO-THERAPEUTICS, INC. 15251 ROOSEVELT BLVD. SUITE 204 CLEARWATER, FL 33760 US 727-538-9570 / 727-538-9570 |
SINGLE USE INJECTION NEEDLES | INJECTION NEEDLES |
| 11 | GIMMI GMBH CARL-ZEISS-STRASSE 6 TUTTLINGEN, D-78532 GM / 49-746-1965900 |
VERESS INSUFFLATION NEEDLE | VERESS NEEDLE |
| 12 | GREENWALD SURGICAL CO., INC. 2688 DEKALB ST. LAKE STATION, IN 46405 US 219-962-1604 / 219-962-1604 |
RESECTOSCOPE INJECTION NEEDLE | ORANDI INJECTION NEEDLE |
| 13 | GYRUS ACMI, INC. 93 NORTH PLEASANT ST. NORWALK, OH 44857 US 011-44-189219750 / 508-804-2739 |
INJECTION NEEDLE | ENDOSCOPES AND ACCESSORIES |
| 14 | HOBBS MEDICAL, INC. 8 SPRING ST. STAFFORD SPRINGS, CT 06076 US 860-684-5875 / 860-684-5875 |
HOBBS MEDICAL INJECTION NEEDLE | INJECTION NEEDLE |
| 15 | HORIZONS INTL. CORP. ZETA FREE ZONE PARK LA VALENCIA HEREDIA, CS 506-261-9114 / 506-261-9114 |
HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES | VARICES NEEDLE |
| 16 | JAPAN ELECTRON BEAM IRRADIATION SERVICE CO., LTD., 4-16 MIDORIGAHARA, TSUKUBA-SHI IBARAKI, 300-2646 JA 813-543-48467 / 484-896-5688 |
OLYMPUS ASPIRATION NEEDLES | VARIOUS TYPES OF ASPIRATION NEEDLES |
| 17 | KARL STORZ GMBH & CO. KG MITTELSTRASSE 8 TUTTLINGEN, 78532 GM 49-74-617080 / 800-421-0837 4201 |
KARL STORZ ENDOSCOPIC NEEDLE | VARIOUS MODELS OF ENDOSCOPIC NEEDLES |
| 18 | MEDICON, E.G. GAENSAECKER 15 TUTTLINGEN, D-78532 GM 49-746-220090 / 49-746-220090 |
NEEDLE, ENDOSCOPIC | NEEDLE, ENDOSCOPIC |
| 19 | MEDI-GLOBE GMBH MEDI-GLOBE-STRASSE, 1-5 ACHENMUHLE, D-83101 GM 49-803-29730 / 480-897-2772 208 |
MULTIPLE | VARIOUS TYPES OF ENDOSCOPIC NEEDLES AND ACCESSORIES |
| 20 | OLYMPUS MEDICAL SYSTEMS CORPORATION 2951 ISHIKAWA-CHO HACHIOJI-SHI, 192-8507 JA / 484-896-5688 |
MULTIPLE | VARIOUS TYPES OF ASPIRATION AND INJECTION NEEDLES |
| 21 | OLYMPUS MEDICAL SYSTEMS CORPORATION 34-3 HIRAI HINODE-MACHI, NISHITAMA-GUN, TOKYO, 190-0182 JA / 484-896-5688 |
MULTIPLE | VARIOUS TYPES OF ASPIRATION AND INJECTION NEEDLES |
| 22 | PHYSION S.R.L. VIA STATALE 12 SUD, 1/B MEDOLLA (MO), 41036 IT 39-053-5611082 / 973-575-0614 |
N-DO INJECTOR PH00961109-1110/1102-1103 | ENDOSCOPY NEEDLE |
| 23 | Q-MED AB SEMINARIEGATAN 21 UPPSALA, SE-752-28 SW 461-847-49000 / 609-269-1100 |
DEFLUX NEEDLE | ENDOSCOPIC NEEDLE |
| 24 | REZNIK INSTRUMENT, INC. 7337 NORTH LAWNDALE SKOKIE, IL 60076 US 847-673-3444 / 847-673-3444 |
ACCESSORIES (PROBES, SUCTION TUBES, NEEDLES, AND ELECTRODES) | ACCESSORIES (PROBES, SUCTION TUBES, NEEDLES, AND ELECTRODES) |
| 25 | TECHNIMEN SKILLERS SMALL INDUSTRIAL ESTATE SIALKOT CITY, PUNJAB, 51340 PK 92-523-561772 / 201-714-7003 |
ACCESSORIES (PROBES, SUCTION TUBES, NEEDLES AND ELECTRODES | VARIOUS TYPES OF ACCESSORIES (PROBES, SUCTION TUBES, NEEDLES AND ELECTRODES) |
| 26 | TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO. SATTLERSTRASSE 11 NENDINGEN, TUTTLINGEN-16, D-78532 GM 004-974-61 1701 0 / 004-974-61 1701 0 |
NEEDLE, ENDOSCOPIC | NEEDLE, ENDOSCOPIC |
| 27 | TELEFLEX MEDICAL 2917 WECK DR. RESEARCH TRIANGLE PARK, NC 27709 US 919-544-8000 / 919-433-4829 |
MULTIPLE ENDOSCOPIC NEEDLES | VARIOUS TYPES OF ENDOSCOPIC NEEDLES |
| 28 | UROPLASTY, INC. 5420 FELTL ROAD MINNETONKA, MN 55343 US 952-426-6140 / 952-426-6158 |
RIGID ENDOSCOPIC NEEDLE | ENDOSCOPIC NEEDLE |
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