Titan OTR Inflatable Penile Prosthesis

  • Modèle / numéro de série
    Lot 1919244.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution -- FL, GA, NC.
  • Description du dispositif
    Coloplast Titan OTR Inflatable Penile Prosthesis,18cm scrotal Bioflex cylinder set w/OTR Pump, P/N QSR9181400. Sterile EO. Manufacturer: Coloplast A/S, 3050 Denmark. Distributed by: Coloplast Corp., Minneapolis, MN 55411 USA. || Indicated for male patients suffering from erectile dysfunction who are considered to be candidates for implantation of a penile prosthesis.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Coloplast Manufacturing US, LLC, 1601 W River Rd, Minneapolis MN 55411-3430
  • Société-mère du fabricant (2017)
  • Source
    USFDA