Devices

Breast localization needle

Fabricant

Medical Device Technologies, Inc.

2 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

Device Recall Hawkins III (BLN) Breast Localization Needle
  • Modèle / numéro de série
    Lot #; 80281L5V
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and to Mexico.
  • Description du dispositif
    Hawkins III Breast Localization Needle. Product number 243075. The product is used in the marking of non-palpable lesions.
  • Manufacturer
    Medical Device Technologies, Inc.
Angiotech Breast Localization Needles
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
    Medical Device Technologies, Inc.