Pentax

  • Modelo / Serial
    Model #EB-1970UK
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
  • Descripción del producto
    Ultrasound Bronchoscope || Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to organs, tissues and subsystems: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Pentax Medical Company, 3 Paragon Dr, Montvale NJ 07645-1782
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

143 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Model #'s FUR-9P and FUR-9RBS
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
  • Descripción del producto
    Ureteroscope || Intended to provide optical visualization of and therapeutic access to the Urinary Track. This anatomy includes but is not restricted to the organs, tissues and subsystems: Urethra, Bladder and Renal Pelvis. The instrument is introduced via the urethra when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
  • Manufacturer
  • Modelo / Serial
    Model #'s FB-10V, FB015BS, FB-15P, FB-15RBS, FB-15V, FB-18BS, FB-18P, FB-18RBS, FB-18V, FB-19TV, FB-8V, EB--1530T3, EB-1170K, EB01570K, EB-1575K, EB-1970K, EB-1970-TK and EB-1975K
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
  • Descripción del producto
    Bronchoscope || Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Nasal Passage, Trachea and Bronchial Tree. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
  • Manufacturer
  • Modelo / Serial
    Model #'s ECN-1530 and FCN-15X
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
  • Descripción del producto
    Choledocho-Nephroscope || Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Biliary tree with access to the Common bile Duct, Hepatic Duct, Cystic Duct, Kidney, Renal Cavity and Renal Calyces. The instrument is introduced via percutaneous cut when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
  • Manufacturer
  • Modelo / Serial
    Model #'s FCP-8P and FCP-9P
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
  • Descripción del producto
    Choledochoscope || Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Common Bile, Hepatic, Cystic and Pancreatic Ducts. The instrument is introduced via the working channel of a Duodenoscope positioned for access to the Common bile Duct when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
  • Manufacturer
  • Modelo / Serial
    Model #'s EC-3430L, EC-3430LK, EC-3470LK, EC-380LKP, EC-3830LK, EC-3930LZ, EC-3831L, EC-3832L, EC-3832LK, EC-3870LK, EC-3870LZK, EC-3872LK, FC-38LV, EC-3830TLK, EC-3832TL, EC-3870TLK, EC-3872TLK, EC-3440L, EC-3840K, EC-2990LI, EC-3490LI, EC-3490LK, EC-3490TLI, EC34-I10L, EC-3890LI, EC-3890LK, EC-3890TLK and EC38-I10L
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
  • Descripción del producto
    Colonoscope || Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
  • Manufacturer
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