Device Recall TLok Ecomony Bone Marrow Tray

  • Modèle / numéro de série
    Catalog # BMET1104ATL Lot Number(s): 81371NG6; 81551NSX; 81691O4Z; 81701O6S; 81771OCG; 82171P26; 82171P27; 82181P33; 82241P64; 82381PGL; 83011QJK; 83241R1U; 83381RA4; 83441RDL; 83531RMF; 90421SKW; 90541SSR; 90611SXW; 90611SZ2; 90821TCV; 90981TQ7; 91131TZP; 91391UIA; 91611UYJ; 91621UZA; 92721X4D; 92721X4E; 92851XBS; 93201XW1; 93211XYM; 93571YK8; 00461ZFC; 00461ZFD; 00681ZS1; 00741ZVY; 0091208V; 013020WJ; 0138212E; 0139213Q; 017621PG; 018221KV; 022822I7; 024622UJ; 0264232Y; 030023R9; 031323X9.
  • 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***T-Lok Ecomony Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - CSR Wrap; 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 1 - Towel; 1 - Probe Guide; 1 - Obturator; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 1 - 2"x3" ADH Dressing***Catalog Number: BMET1104ATL***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

2 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Catalog # BMET0804TL Lot Number(s): 81771OCF; 82101OW8; 82521PR1; 82831Q9P; 83391RAT; 90471SMZ; 90611SXN; 91411UKZ; 91631UZH; 91881VHH; 91881VHI; 92301WCA; 92581WS8; 93291Y3R; 00151YW4; 00611ZPG; 013020WF; 0138212P; 01402159; 017321N8; 0207225W; 023922PT.
  • 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***T-Lok Ecomony Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 8ga x 4" Bone Marrow Needle "J" Type; 1 - 16ga x 2.688" Bone Marrow Needle "I" Typ; 1 - 2"x3" ADH Dressing; 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 1 - Obturator; 1 - Male Luer Cap; 1 - Probe Guide; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - T-Lok Extraction Cannula; 1 - Towel; 1 - CSR Wrap ***Catalog Number: BMET0804TL***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
  • Modèle / numéro de série
    Catalog # BMET1104TL Lot Number(s): 81371NG7; 81701O6T; 81701O6U; 81721O96; 81771OCH; 82101OWJ; 82171P28; 82181P34; 82201P58; 82331PE9; 82381PGM; 82961QGO; 82961QGP; 83011QJ8; 83161QVI; 83371R7W; 83391RAC; 83521RMA; 90081RTH; 90141RY4; 90471SLL; 90471SLM; 90971T45; 91131U0P; 91131U0Q; 91311UAO; 91331UD5; 91341UFQ; 91391UI9; 91411UKJ; 92031VT8; 92031VT9; 92081VUS; 92081VUT; 92381WGS; 92661WYV; 92661WYW; 92661WYX; 92721X4I; 92721X4J; 92851XBI; 93201XW6; 93211XYS; 93291Y3U; 93491YF6; 93521YHM; 93571YKM; 00561ZM5; 00681ZRF; 00741ZW7; 011820P9; 013020WH; 0138212H; 015221AQ; 015321BP; 015321BQ; 017621PB; 017621PC; 0208227D; 022822I6; 024622UG; 02602316; 02642331; 029423O7; 030023RA; 03192416.
  • 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***T-Lok Ecomony Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 11ga x 4" Bone Marrow Needle "J" Type; || 1 16ga x 2.688" Bone Marrow Needle "I" Typ; 1 - 3" x 3" Sponges (4-Ply); 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 1 - Probe Guide; 1 - Obturator; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 1 - Towel; 1 - 2"x3" ADH Dressing; 1 - CSR Wrap; ***Catalog Number: BMET1104TL***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