Integra

  • Modèle / numéro de série
    Strip Part Number 7701513001  510 K- K063124 Device Listing Number - D001098  Integra MOZAIKTM Strip IOcc Reference number - CCM I021OITL Batch Number - 105BR0215955  Integra MOZAIKTM Strip 10cc Reference Number - CCM I021OITL Batch Number - 105BR0216149
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution
  • Description du dispositif
    Integra Mozaik Strip || 10 cc || Product Usage: || The product is a bone graft substitute composed of collagen (Type 1) and ceramic (I3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine. and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bone void or a defect Integra Mozaik is reabsorbed and replaced with bone during the healing process.
  • Manufacturer
  • 1 Event

Fabricant

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  • Modèle / numéro de série
  • Manufacturer
    N/A
  • Modèle / numéro de série
    6802413, Software Version 3.2.2 and earlier.
  • Description du dispositif
    This equipment is indicated for use in in vitro diagnostics in quantitative, semiquantitative and qualitative in vitro measurement of different analytes of clinical interest.
  • Manufacturer
  • Modèle / numéro de série
    Concerning calibration discs reference 6801876, Release version of data 5873, 5874, 5875 and 5876.
  • Description du dispositif
    This equipment is indicated for use in in vitro diagnostics in quantitative, semiquantitative and qualitative in vitro measurement of different analytes of clinical interest.
  • Manufacturer
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