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SKIN STAPLER HANDLE, K801445
 Request for Information Form |
 Contact Information
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| Company Name | TELEFLEX MEDICAL |
| Address | 2917 WECK DR. |
| City, State, Zip | RESEARCH TRIANGLE PARK, NC 27709 |
| Country | US |
| FDA Owner/Operator Phone | 919-544-8000 |
| FDA Medical Specialty Code | SU - General Plastic Surgery |
| FDA Product Code | GAG |
| FDA Classification Name | STAPLER, SURGICAL |
| FDA Device Classification Code | General Controls |
| FDA Regulation Number | 878.4800 |
| FDA Common Generic Name | SKIN STAPLER HANDLE, K801445 |
| FDA Proprietary Device Name | SKIN STAPLER HANDLE, K801445 |
| FDA Owner / Operator Number | 9062981 |
| FDA Owner / Operator Name | TELEFLEX MEDICAL |
| FDA Establishment Registration Number | 1044475 |
| FDA Registered Establishment Name | TELEFLEX MEDICAL |
| FDA Operation Code(s) |
MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller |
| FDA Listing Date | 03-14-95 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of TELEFLEX MEDICAL
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 |
MANIPLER AZ | SURGICAL STAPLER |
| 2 | AFZIMA CO., LTD. RM 501 HANVIT BLDG. 593-3 SAMBANG-DONG GIMHAE-SI, KYOUNGSANGNAM-DO, 621-909 KS 82-55-338 9162 / 267-210-9365 |
SKIN STAPLER | MANUAL SURGICAL STAPLER |
| 3 | AVAIL MEDICAL PRODUCTS, INC. 1900 EAST CARNEGIE AVE. SANTA ANA, CA 92705 US 817-877-4343 / 949-263-5060 341 |
MULTIPLE | SKIN STAPLER & ACCESSORIES |
| 4 | B BRAUN SURGICAL, SA CARRETERA DE TERRASSA 121 RUBI, 08191 SP 49-74-6195-1548 / 610-984-9074 |
MANIPLER AZ | STAPLER |
| 5 | BAUSCH & LOMB, INC. 499 SOVEREIGN CT. MANCHESTER, MO 63011 US 585-338-6000 / 585-338-8731 |
APPOSE @ SKIN STAPLER | APPOSE @ SKIN STAPLER |
| 6 | CM INSTRUMENTE GMBH GANSACKER 56 TUTTLINGEN, BW, DE, 78532 GM 49-074-622042061 / 49-074-622042061 |
CM SURGICAL STAPLER | SURGICAL STAPLER |
| 7 | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES 60 MIDDLETOWN AVENUE NORTH HAVEN, CT 06473 US 508-261-8587 / 203-492-5157 |
MULTIPLE | STAPLER SURGICAL |
| 8 | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES 150 GLOVER AVE. NORWALK, CT 06856 US 508-261-8587 / 203-492-5157 |
MULTIPLE | STAPLER SURGICAL |
| 9 | CP MEDICAL 803 NE 25TH AVE. PORTLAND, OR 97232 US 770-271-0233 / 503-445-1635 |
XACT SURGICAL STAPLER | SURGICAL STAPLER |
| 10 | DEMETECH CORP. 3530 N.W. 115TH AVE. MIAMI, FL 33178 US 305-597-5277 / 305-597-5277 |
GAG | DISPOSABLE SKIN STAPLER |
| 11 | DEROYAL SURGICAL - ROSE HILL 100 ROSE HILL INDUSTRIAL PARK ROSE HILL, VA 24281 US 865-938-7828 / 865-938-7828 1325 |
SURGICAL STAPLER | SURGICAL STAPLER |
| 12 | DEROYAL TECHNOLOGIES, INC. 1211 HWY. 33 SOUTH NEW TAZEWELL, TN 37825 US 865-938-7828 / 865-938-7828 1325 |
VARIOUS SURGICAL STAPLERS | VARIOUS SURGICAL STAPLERS |
| 13 | DIMEDA INSTRUMENTE GMBH GANSACKER 58 TUTTLINGEN, D-78502 GM 49-74-62-9461-0 / 49-74-62-9461-0 |
MULTIPLE PRIVATE LABEL | VARIOUS TYPES OF SURGICAL STAPLER |
| 14 | ETHICON, INC. 3348 PULLIAM ST. SAN ANGELO, TX 76905 US 908-218-2887 / 908-218-2996 |
SURGICAL STAPLER | VARIOUS TYPES OF SURGICAL STAPLERS |
| 15 | HUBEI TIAHUI MEDICAL INSTRUMENTS LTD. NO. 95-5 TANXI RD. XIANGFAN, HUBEI, CH 86-710-3212901 / 86-710-3212 901 |
SKIN STAPLER | SKIN STAPLER |
| 16 | IMPERIAL ORTHOFLEX MFG., LTD. 205-5920 # 6 RD. RICHMOND, B.C., V6V 1Z1 CA 604-270-3330 / 604-948-5280 |
NO PROPRIETARY NAME LISTED | NO COMMON NAME LISTED |
| 17 | INCISIVE SURGICAL, INC. 14405-21ST AVE. NORTH PLYMOUTH, MN 55447 US / 952-591-2543 14 |
INSORB-25 SUBCUTICULAR SKIN STAPLER CAT. NO. 1025 | SURGICAL STAPLER |
| 18 | IRONWOOD PLASTICS, INC. 1235 WALL ST. IRONWOOD, MI 49938 US 906-932-5025 510 / 906-932-5025 510 |
SR III | SURGICAL STAPLE REMOVER |
| 19 | MANI, INC. (HEAD OFFICE) 8-3 KIYOHARA INDUSTRIAL PARK UTSUNOMIYA-SHI, TOCHIGI-KEN, 321-3231 JA 81-028-6753311 / 201-891-1466 |
MANIPLER DISPOSABLE SKIN STAPLER | SURGICAL SKIN STAPLER |
| 20 | MANI, INC. (TAKANEZAWA FACILITY) 743 NAKAAKUTSU TAKANEZAWA-MACHI TOCHIGI-KEN, 329-1234 JA 81-028-6753311 / 410-793-0484 |
MANIPLER DISPOSABLE SKIN STAPLER | SURGICAL SKIN STAPLER |
| 21 | MEDISISS 2747 SW 6TH STREET REDMOND, OR 97756 US 541-923-3310 / 541-923-3310 |
MULTIPLE | VARIOUS SURGICAL STAPLERS,STERILE |
| 22 | NELLCOR PURITAN BENNETT MEXICO, S.A. DE C.V. 37 BLVD. INSURGENTES, LIBRIAMENTO A LA P., LA MESA TIJUANA, B.C., MX 925-463-4371 / 925-463-4000 |
APPOSE | SKIN STAPLER, ULC DISPOSABLE, ULTRA UNITY, DISPOSABLE, STAPLES & REMOVER |
| 23 | NORTHEAST SCIENTIFIC, INC. 29 SOUTH COMMONS ROAD WATERBURY, CT 06704 US 203-756-2111 / 203-756-2111 |
NES REPROCESSED SURGICAL STAPLER | SURGICAL STAPLER, STAPLE GUN |
| 24 | SHAANXI CREATION MEDICAL APPLIANCES CO., LTD. C. 4/F,BLDG.3, NO.1,TORCH RD. XIAN, SHAANXI, 710043 CH 86-29-2682867 / 86-29-82682867 |
DISPOSABLE SKIN STAPLER | DISPOSABLE SKIN STAPLER |
| 25 | SHANGHAI DOKIND MEDICINE SCIENCE & TECH CO., LTD. NO.4579 XIAOZHENGSONGZHENG RD LIANTANG TOWN, QINGPU DISTRICT SHANGHAI, 201716 CH 86-21-58358403 / 86-21-58358403 |
SURGICAL STAPLER | SURGICAL STAPLER |
| 26 | STERILMED, INC. 11400 73RD AVE. NORTH, #100 MAPLE GROVE, MN 55369 US 763-488-3400 / 763-488-3410 |
N/A | STAPLER |
| 27 | STRYKER ENDOSCOPY 5900 OPTICAL CT. SAN JOSE, CA 95138 US 269-385-2600 / 408-754-2124 |
HERNIASTAT | |
| 28 | SWISS SURGICAL INSTRUMENTS AG 34, NETZIBODENSTRASSE PRATTELN, BASELLAND, 4133 SZ 41-61-8259080 / 41-61-8259080 |
SURGICAL STAPLER | SURGICAL STAPLER |
| 29 | TECHNIMEN SKILLERS SMALL INDUSTRIAL ESTATE SIALKOT CITY, PUNJAB, 51340 PK 92-523-561772 / 201-714-7003 |
VARIOUS TYPE OF RETRACTORS, ALM, BALFOUR, SURGICAL & DENTAL | VARIOUS TYPE OF RETRACTORS, ALM, BALFOUR, SURGICAL & DENTAL |
| 30 | TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO. SATTLERSTRASSE 11 NENDINGEN, TUTTLINGEN-16, D-78532 GM 004-974-61 1701 0 / 004-974-61 1701 0 |
NO PROPRIETARY NAME LISTED | VARIOUS TYPES OF STAPLER, SURGICAL |
| 31 | TOHA PLAST GMBH GUSTAV-BIELEFELD-STRASSE 8 GOETTINGEN, 37079 GM 49-551-504500 / 49-551-50450-27 |
STAPLER SURGICAL, STAPLE REMOVER | SKIN STAPLER, STAPLE REMOVER |
| 32 | USSC PUERTO RICO, INC. BUILDING 911-67 SABANETAS INDUSTRIAL PARK PONCE, PR 00731 US 508-261-8587 / 203-492-5157 |
MULTIPLE | STAPLER SURGICAL |
| 33 | ZIMMER, INC. 345 E. MAIN ST. WARSAW, IN 46580 US 800-613-6131 / 574-372-4485 |
MULTIPLE | STAPLERS |
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