Angiotech Breast Localization Needles

  • Modelo / Serial
    A) 90621SZN, 91051TTN, 91591UV4, 90571SVW, 90571SVX, 90681T3E, 90911TK7, 91181TW9, 91271U9Y, 91561UU6, 90571SUJ, 90571SUK, 90681T46, 90831TA6, 90921TKY, 90961TLT, 91051TTS, 91131TZD, 91131U08, 91201U5P, 91471UNO, 91541US2, 91631UZT, 90891TGR, 90701T5A, 90961TM1, 91031TM2, 91341UF3, 91481UO9, 90751T6X, 90751T6Y, 91051TTL, 91131TZ7, 91541US1, 91551UT0, 90491SOM, 90821T2V, 91061TTU, 91121TXX, 91041TOI .   B) 90551STU, 91461ULZ, 91491UPP, 90551STT, 90681T42, 90921TKW, 90901TIZ, 91561UTY, 90541SRB, 91171TW7, 91311UBE, 90681T3N, 91311UBF, 91481UOA, 90541SS4, 90701T5G, 90971TOJ, 91171U2A, 91461UMQ, 90611SY7, 90891TH1, 91131TZT, 91471UNJ.   C) 91331UCJ, 90571SW1, 90641T1V, 91181U2T, 90551SUD, 90611SXX, 90901TJ3, 91271U9X, 91461UML, 90571SUV, 90821TCM, 90961TM3, 91411UKL, 90551SUE, 90641T1W, 90821TCN, 91061TUI, 91341UFK, 91461UMK, 91681V2T, 90611SXV, 90701T5M, 91131TZK, 91271U9V, 90641T22, 90681T39, 90681T3A, 90771T9T, 90821TCW, 90901TIK, 90971TNO, 91051TTT, 91271UA4, 91331UCR, 90551SU9, 90551SUA, 90571SVT, 90771TAE, 90891THJ, 91061TUP, 91331UCQ, 91471UNM, 91551UT2, 91741V6K.   D) 90411SIV, 90541SSU, 90641T1Y, 91131TZS, 90541SRF, 90631T0Z, 90751T7Q, 90841TEE, 91031TRX, 91271UA0, 91341UFS, 91391UHY, 90541SSD, 90781TBI, 90901TJA, 91271TUQ, 91491UPH, 91551UT3, 90901TJ8, 91561UU7, 90981TPU, 91131TZU.   E) 90611SYG, 91131TZB.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BERMUDA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, ESTONIA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PERU, PHILIPPINES, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, and UNITED ARAB EMIRATES.
  • Descripción del producto
    Angiotech Breast Localization Needles: || A) Accura BLN and Accura II BLN with Stiffening Cannula, STERILE. || Product Numbers: BLN2003, BLN2005, BLN20075, BLN2103, BLN2105, BLN21075, 266050, 266075. 510k K974741 Qty Dist. - 14,800. || B) Hawkins I BLN; Hawkins II Hardware BLN, Hawkins II Flexstrand BLN. STERILE. || Product Numbers: 251050, 251075, 251100, 242050, 242075, 252050, 252075. 510k K870523 Qty Dist. - 6,420. || C) Hawkins III Hardwire BLN, Hawkins III Hardwire BLN with Echogenic Tip, Hawkins III Flextrand BLN. STERILE. || Product Numbers: 243030, 243050, 243075, 244030, 244050, 244075, 253030, 253050, 253075. 510k 870523 Qty Dist. - 15,440. || D) Homer Mammalok Gold Improved Tensile Strength. STERILE. || Product Numbers: 231030G, 231050G, 231075G, 231100G, 231125G. || 510k Exempt. Qty Dist. - 21,780. || E) "D" Wire BLN. STERILE. || Product Numbers: BLND20075. 510k K974741 Qty Dist. 230 || MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. || Intended use: Breast Localization Needle
  • Manufacturer
  • 2 Events

Fabricante

  • Dirección del fabricante
    Medical Device Technologies, Inc., 3600 Sw 47th Ave, Gainesville FL 32608-7555
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA