Device Recall HSG Procedure Tray 5Fr

  • Modèle / numéro de série
    Catalog # 660005000 Lot Number(s): 81561NUN; 81561NUO; 81581NW4; 81961OM8; 82061OU8; 82121OY5; 82341PEQ; 82461PLA; 82521PQ0; 82811Q75; 82821Q7N; 82871QAN; 82901QDL; 83111QRI; 83251R2O; 83291R3V; 83391R9U; 90191S0X; 90261S5Q; 90261S5R; 90271S87; 90361SFQ; 90471SM9; 90611SYH; 90681T3K; 90751T6T; 91061TUC; 91201U5F; 91201U5G; 91211U6O; 91211U6P; 91411UKV; 91981VPX; 92031VTV; 92151W0I; 92251W8T; 92661WXJ; 92681X1E; 92721X4R; 92801X8L; 92861XCN; 92861XCX; 93001XLL; 93081XPK; 93351Y5B; 93351Y5C; 93421YAX; 93501YGQ; 00041YNO; 00391Z97; 00431ZD4; 00611ZPB; 009620AK; 010420GG; 012020QR; 013220Z4; 015221AO; 018121RH; 019321U6; 02102299; 021422A7; 022422HF; 023522N5; 0265234L; 02732396; 028523IF.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.
  • Description du dispositif
    Angiotech***HSG Procedure Tray 5Fr***1 - 18ga x 1-1/2" Needle; 1 - Fenestrated Drape; 1- 20cc Syringe L/L; 1 - Povidone-Iodine Ointment (1g); 2 - Povidone-Iodine Solution (1oz); 1 - Sanitary Napkin; 2 - Sponge Sticks (6"); 1 - Sound Dilator; 1 - Autobag; 1 - Lubricating Jelly; 2 - Cotton Tipped Swab (8"); 1 Extension Tubing (30"); 2 - 3"x3" Sponges (12-Ply); 1 - Vaginal Speculum; 1 - HSG Catheter (5Fr); 1 - Fixed Volume Syringe - 2cc; 1 - CSR Wrap (30"x30")***Catalog Number: 660005000***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. || MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, customer_service@angio.com, www.angiotech.com. || HSG Catheters are intended for use in the injection of contrast material in the examination of the uterus and fallopian tubes.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Medical Device Technologies, Inc., 3600 Sw 47th Ave, Gainesville FL 32608-7555
  • Société-mère du fabricant (2017)
  • Source
    USFDA