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GYNETECH P.P.S. (TM)
 Request for Information Form |
 Contact Information
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| Company Name | GYNECONCEPTS INC., A DELAWARE CORPORATION |
| Address | SCRIPPS CTR. 312 WALNUT ST.
16TH FLOOR |
| City, State, Zip | CINCINNATI, OH 45202 |
| Country | US |
| FDA Owner/Operator Phone | 513-352-0240 |
| FDA Medical Specialty Code | OB - Obstetrics/Gynecology |
| FDA Product Code | HHT |
| FDA Classification Name | SPATULA, CERVICAL, CYTOLOGICAL |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 884.4530 |
| FDA Common Generic Name | CELL COLLECTOR/TRANSPORT SYSTEM FOR GYNECOLOGICAL SMEARS ("PAP SMEARS") |
| FDA Proprietary Device Name | GYNETECH P.P.S. (TM) |
| FDA Owner / Operator Number | 9022993 |
| FDA Owner / Operator Name | GYNECONCEPTS INC., A DELAWARE CORPORATION |
| FDA Establishment Registration Number | 1648569 |
| FDA Registered Establishment Name | GYNECONCEPTS INC., A DELAWARE CORPORATION |
| FDA Operation Code(s) |
MS - Specification Developer |
| FDA Listing Date | 10-16-95 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of GYNECONCEPTS INC., A DELAWARE CORPORATION
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 | AMSINO INTERNATIONAL, INC. 855 TOWNE CENTER DR. POMONA, CA 91767 US 909-626-5888 / 909-626-5888 |
MULTIPLE | CERVICAL SCRAPER |
| 3 | ANDWIN SCIENTIFIC 6636 VARIEL AVE. WOODLAND HILLS, CA 91303 US 818-999-2828 / 818-999-2828 270 |
MULTIPLE | SCRAPER, BRUSH |
| 4 | BECTON, DICKINSON & CO. 7 LOVETON CIR. SPARKS, MD 21152 US 201-847-6800 / 410-316-4000 4099 |
AYRE CERVI-SCRAPER | AYRE CERVI-SCRAPER |
| 5 | BENXI JINSHUO APPLICATOR CO., LTD. INDUSTRIAL ZONE, SHI QIAO ZI DEVELOPING ZONE, BENXI LIAONING, 117004 CH 86-414-5859898 / 86-414-5859898 |
MULTIPLE | SPATULA, CERVICAL, CYTOLOGICAL |
| 6 | BIO NUCLEAR DIAGNOSTICS, INC. 1791 ALBION RD. TORONTO, ONTARIO, M9W 5S7 CA 416-674-1545 / 416-674-1545 |
CYTO BRUSHES | CYTO BRUSHES |
| 7 | CANADIAN MEDICAL BRUSH, INC. 7065 FIR TREE DRIVE MISSISSAUGA, ONTARIO, L55 1J7 CA 905-405-1075 / 905-405-1075 |
NON STERILE CYTOLOGY BRUSH CMB 1010 | NON STERILE CYTOLOGY BRUSH CMB 1010 |
| 8 | CELLPATH, PLC UNIT 66, MOCHDRE ENTERPRISE PARK NEWTOWN, POWYS, WALES, SY16 4LE UK 44-168-6611333 / 44-168-6611333 |
CELLPATH AYLESBURY CERVICAL SPATULA | AYLESBURY SPATULA |
| 9 | CHANGCHUN KANGDA MEDICAL SUPPLY CO., LTD. 4 HUO JU RD. CHANGCHUN, CH 86-431-5179786 / 909-390-5688 |
AMSINO CERVICAL SCRAPER | VARIOUS STYLES OF AMSINO CERVICAL SCRAPERS |
| 10 | CHINA SHENYANG MED-LAND IMP/EXP CORP., LTD. INTERNATIONAL TRADE BUILDING NO. 35 THE YOUTH ST., SHENHE DISTRICT, SHENYANG, 110014 CH / 631-805-8881 |
SPATULA, CERVICAL, CYTOLOGICAL | SPATULA, CERVICAL, CYTOLOGICAL |
| 11 | COMBINED INSTRUMENTS (PVT.), LTD. 13-A MODEL TOWN, UGOKI SAILKOT, PK 04-32-510243 / 05-24-510243 |
SPATULA, CERVICAL, CYTOLOGICAL | SAME |
| 12 | CONTRACT MEDICAL MANUFACTURING LLC 1 JACKS HILL ROAD OXFORD, CT 06478 US 203-888-1430 / 203-888-1430 33 |
DRG SOFT RELEASE | CERVICAL SPATULA |
| 13 | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. SPENCER, IN 47460 US 812-829-4891 / 812-829-4891 |
MULTIPLE | VARIOUS SIZES OF STERILE AND NON-STERILE CYTOLOGY BRUSHES |
| 14 | COOPERSURGICAL, INC. 95 CORPORATE DR. TRUMBULL, CT 06611 US 203-601-9825 / 203-601-5200 9825 |
SPATULAS/BRUSHES, MULTIPLE, CYTOLOGICAL | PAP KITS, CERVICAL SAMPLING DEVICES |
| 15 | CYTOPREP INC. EST. RENKWILER 37 ESCHEN, 9492 LS 432-373-76 76 / 423-373-76 76 |
CYTOPREP | CERVICAL BRUSH |
| 16 | DALIAN GOODWOOD WOODEN PRODUCTS FACTORY YOUJIACUN, XINZHAIZI TOWN, GANJINGZI DISTRICT DALIAN CITY, 116039 CH 86-411-6300615 / 909-626-5888 |
MULTIPLE | CERVICAL SCRAPER |
| 17 | DALIAN YONGFENG WOODEN PRODUCTS CO., LTD. 74, LUXUN ROAD DALIAN, LIAONING PROVINCE, 116001 CH 86-411-82707474 / 86-411-82707474 |
SPATULA, CERVICAL SCRAPER | SPATULA, CERVICAL SCRAPER |
| 18 | DEPUY INTL., LTD. ST. ANTHONY'S RD. LEEDS, LS11 8DT UK 574-267-8143 4906 / 574-371-4906 |
AYRES CERVICAL SPATULA | AYRES CERVICAL SPATULA |
| 19 | DIAMICS, INC. SIX HAMILTON LANDING SUITE 200 NOVATO, CA 94949 US 415-883-0414 20 / 415-883-0414 20 |
CERCOL CERVICAL SAMPLE COLLECTOR | CERCOL CERVICAL SAMPLE COLLECTOR |
| 20 | DIGENE CORP. 1201 CLOPPER RD. GAITHERSBURG, MD 20878 US 301-944-7115 / 301-944-7259 |
DIGENE CERVICAL SAMPLER | CERVICAL BRUSH AND SPECIMEN TRANSPORT MEDIA (STM) |
| 21 | DR. REZA S. MOHAJER 3926 SAPPHIRE DR. ENCINO, CA 91436 US 818-986-1461 / 818-986-1461 |
CELL SWEEP | PAP SMPLER. |
| 22 | DYNAMIC SURGICAL (PVT) LTD WAZIRABAD RD UGOKI SIALKOT, PK 92-52-3510268 / 92-52-3510268 |
SPATULA CERVICAL CYTOLOGICAL | SPATULA CERVICAL CYTOLOGICAL |
| 23 | FANG LIN WOODEN PRODUCTS CO. LTD. SHIH CHIAO TZU CHEN BENXI ECO. N TECH. DEVEP. ZONE BENXI, LIAONING, 117004 CH 86-414-585 1608 / 86-414-585 1608 |
MULTIPLE | WOODEN CERVICAL SCRAPERS |
| 24 | GYNEX CORP. 2789 152ND AVE., NE REDMOND, WA 98052 US 425-882-1179 / 425-882-1179 |
ECTO-BRUSH | CYTOLOGY BRUSH |
| 25 | INNOVATEK MEDICAL, INC. 1600 DERWENT WAY, UNIT #3 DELTA, BC, V3M 6M5 CA 604-522-8303 / 800-563-3977 |
CERVICAL SCRAPER | CERVICAL SCRAPER |
| 26 | JIANGSU SUYUN MEDICAL MATERIALS CO., LTD NO.1 MEDICINE LANE,RENMIN RD., LIANYUNGANG, JIANGSU, 222002 CH 86-518-5476682 / 630-627-4105 |
CELL-SWEEP | CERVICAL SAMPLER |
| 27 | KARL HAMMACHER GMBH STEINENDORFERSTR. 27 SOLINGEN, D-42699 GM / 212-262-500 |
NO PROPRIETARY NAME LISTED | NO COMMON NAME LISTED |
| 28 | KENTRON HEALTH CARE, INC. 3604 KELTON JACKSON ROAD P.O. BOX 120 SPRINGFIELD, TN 37172 US 615-384-0573 / 615-384-0573 |
KENOREX CERVICAL SCRAPERS | WOODEN CERVICAL SCRAPERS |
| 29 | LABORATOIRES PRODIMED ZI, 4 RUE DE L'EUROPE NEUILLY-EN-THELLE, 60530 FR / 33-344-266346 |
MULTIPLE | VARIOUS |
| 30 | LONGWIN PLASTICS CO., LTD. 20-220, SAN MIN RD., SEC. 2 PAN CHIAO TAIPEI, TW 886-296-26058 / 415-495-2495 |
CERVICAL SPATULA | CERVICAL SPATULA OR SCRAPER |
| 31 | MEDICAL ENGINEERING CORP. S.A. 639 SANCHEZ DE LORIA CIUDAD DE BUENOS AIRES, C1220ADA AR 005-411-4957 3009 / 005-411-4343 4241 |
MULTIPLE | STERILE AND NON-STERILE ENDOCERVICAL CELL COLLECTOR BRUSH |
| 32 | MEDVENTURES INT'L, INC. 7215 SOUTH TOPEKA BLVD. #2704E2 TOPEKA, KS 66619 US 785-862-2300 / 785-862-2300 |
PAP SMEAR KIT | PAP SMEAR KIT |
| 33 | MERCEDES MEDICAL, INC. 7590 COMMERCE COURT SARASOTA, FL 34243 US 941-355-3333 / 941-355-3333 228 |
CYTOLOGY BRUSH | CYTOLOGY BRUSH |
| 34 | NEWTECH INDUSTRIES CO. LTD. 452-9 DAEHUNG-DONG JUNG-GU TAEJEON CHOUNGNAM, 300-090 KS 42-253-3105 / 909-980-9933 |
MDB-5 (BRUSH) | MEDICAL BRUSH |
| 35 | NORTH EOS INDUSTRIES, INC. 20-8, LANE 252, TUNG CHI ST., TUNG-SHIH TAICHUNG, HSIEN, 423 TW 425-87-5000 / 42-587-5000 |
"EOS" BRAND | EOSSMEAR |
| 36 | PURITAN MEDICAL PRODUCTS COMPANY LLC 31 SCHOOL ST. P.O. BOX 149 GUILFORD, ME 04443 US 207-876-3311 / 207-876-3311 207 |
CERVICAL CYTOLOGY BRUSH | CERVICAL BRUSH/STERILE AND NON STERILE CYTOLOGY BRUSH |
| 37 | RECE INTERNATIONAL CORP. 5881 N.W. 151ST ST., STE. 111 MIAMI LAKES, FL 33014 US 305-362-6555 / 305-362-6555 |
VIAMED CYTOLOGY BRUSH | CYTOLOGY BRUSH |
| 38 | ROVERS MEDICAL DEVICES B.V. LEKSTRAAT 10 OSS, 5347 KV NL 011-314-12648870 / 011-314-12648870 |
ENDOCERVEX-BRUSH | ENDOCERVEX-BRUSH |
| 39 | SAKURA FINETEK U.S.A., INC. 1750 WEST 214TH ST. TORRANCE, CA 90501 US 81-332-701666 / 310-783-5076 |
CYTO-TEK SPATULA | CYTOSPATULA |
| 40 | SHANGHAI OIFAN I/E CO., LTD. 25/F BAODING MANSION, NO. 55 XU JIA HUI RD. SHANGHAI, 200025 CH |
SAFETEX CERVICAL SPATULA (PLASTIC) 510K | PLASTIC SCRAPER |
| 41 | SOLON MANUFACTURING COMPANY 338 MADISON AVENUE SUITE 7 SKOWHEGAN, ME 04976 US 207-474-6213 / 207-858-1540 |
NYLON CYTOLOGY BRUSH (STERILE & NON STERILE) | CYTOLOGY BRUSH (STERILE & NON STERILE) |
| 42 | STRYKER LEIBINGER GMBH & CO. KG BOTZINGER STRASSE 41 FREIBURG, D-79111 GM 269-385-2600 / 49-761-4512x185 |
MULTIPLE | VARIOUS TYPES OF SPATULA, CERVICAL, CYTOLOGICAL |
| 43 | SURGICON (PVT) LTD. P.O. BOX 244 KHADIM ALI RD. SIALKOT, PUNJAB, PK 92-432-262530 31 / 92-432-262531 32 |
SPATULA CERVICAL CYTOLOGICAL | SPATULA CERVICAL CYTOLOGICAL |
| 44 | SURGIPATH MEDICAL INDUSTRIES, INC. 5205 RT. 12 RICHMOND, IL 60071 US 815-678-2000 / 815-678-2000 120 |
NO PROPRIETARY NAME LISTED | NO COMMON NAME LISTED |
| 45 | TEAM TECHNOLOGIES, INC. 5949 COMMERCE BLVD. MORRISTOWN, TN 37814 US 423-587-2199 / 423-587-2199 |
SPATULA, CERVICAL, CYTOLOGICAL | TWISTED WIRE BRUSH |
| 46 | 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 | SPATULA, CERVICAL, CYTOLOGICAL |
| 47 | THERAPAK CORP. 1801 HIGHLAND AVE. UNIT K DUARTE, CA 91010 US 626-599-9952 / 626-599-9952 |
ROVERS CERVIX BRUSH | CERVICAL CELL SCRAPER |
| 48 | THERAPAK CORPORATION 4305 HAMILTON MILL RD. SUITE 200 BUFORD, GA 30518 US 626-599-9952 / 626-599-9952 225 |
ROVERS ENDOCERVEX BRUSH, ROVERS SPATULA, ROVERS CERVEX BRUSH | CERVICAL CELL SCRAPER |
| 49 | TRI-STATE HOSPITAL SUPPLY CORP. 301 CATRELL DR. HOWELL, MI 48843 US 517-545-1122 / 800-248-4058 1135 |
CERVICAL SCRAPER | CERVICAL SCRAPER |
| 50 | TRI-STATE HOSPITAL SUPPLY CORP. 3173 EAST 43RD ST. YUMA, AZ 85365 US 517-545-1122 / 800-248-4058 1135 |
CERVICAL SCRAPER | CERVICAL SCRAPER |
| 51 | TRI-STATE HOSPITAL SUPPLY CORP. 3310 SOUTH MAIN ST. SALISBURY, NC 28147 US 517-545-1122 / 800-248-4058 1135 |
CERVICAL SCRAPER | CERVICAL SCRAPER |
| 52 | WALLACH SURGICAL DEVICES, INC. 235 EDISON RD. ORANGE, CT 06477 US 203-601-9825 / 203-601-9825 |
NO PROPRIETARY NAME LISTED | CERVICAL SPATULA |
| 53 | YOUNG OU CO., LTD. 300-1 SANGYE-REE POGOK-UP, CHEOIN-GU YONGIN-CITY KYUNGKI-DO, KS 031-333-0512 / 031-333-0512 |
PAP BRUSH | ENDOCERVICAL BRUSH |
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