Device Recall General Biopsy Tray

  • Modèle / numéro de série
    Catalog # GUTS1000 Lot Number(s): 81401NHR; 81551NSZ; 81631NZT; 81771OCO; 81911OKS; 82101OWA; 82321PDO; 82381PG9; 82381PGA; 82521PQA; 82521PQB; 82691Q0C; 82731Q2B; 82871QAI; 82881QBS; 82941QEQ; 82961QGR; 83031QLP; 83161QW2; 83171QXI; 83391RAX; 83521RM8; 83531RME; 90051RNB; 90191S0V; 90191S0W; 90271S9J; 90331SCJ; 90471SLP; 90631T1N; 90631T1O; 90701T57; 90761T8G; 90901TJB; 90981TQ6; 91051TTP; 91171U22; 91341UFU; 91391UIB; 91411UKF; 91411UKG; 91531UQW; 91531URF; 91591UVM; 91701V4V; 91891VIV; 92251W8Y; 92261WAX; 92261WAY; 92381WH9; 92521WOL; 92531WPZ; 92531WQ0; 92581WS9; 92711X37; 92711X38; 92791X8E; 93031XNU; 93141XT6; 93291Y3V; 93431YCE; 93481YEG; 93561YIX; 00151YWB; 00191YXZ; 00201YZ3; 00461ZF7; 00611ZPA; 00621ZPT; 00631ZQZ; 009720C7; 010220EO; 010320G0; 010920IB; 012420T1; 012520UN; 013020WS; 013120Y1; 01372117; 01462188; 017921PX; 018321TF; 018721U0; 0263232N; 0264233Q; 02662350; 0267235M; 0267235N; 028723JD; 028723JE; 028823K0; 028823K1; 029323N1.
  • Classification du dispositif
  • Classe de dispositif
    1
  • 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***General Biopsy Tray*** 1 - 20cc Syringe L/L; 1 - 10cc Syringe L/L; 1 - 5cc Syringe L/L; 1- 25ga x 5/8" Needle; 1 - 21ga x 1-1/2" Needle;1- 19ga x 1-1/2" Filter Needle; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 1 - 1% Lidocaine (5mL); 1 - #11 Mini Scalpel; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - ¿" x 3" Bandage; 2 - Towel; 1 - Fenestrated Drape; 2 - 15mL Specimen Tube; 2 - Specimen Label; 1 - Ruler; 1 - CSR Wrap***Catalog Number: GUTS1000***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. || Intended for the purpose of harvesting bone and/or bone marrow specimens.
  • 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