Page 3 - Concelltrate 100 - 2019
P. 3

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           ConCelltra1e 100  is  provide,d  sterile  with  a  medical device  Stenlity  Assurance  evel  (SAL)  1 o .  The  product  should  be
           stored in ambient temperatures and has a shelf life of five years from the da e of packaging.
                                                              CellRight Technologies employs strict quality assurance and
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                                                              quality control procedures to ensure patient safety.
                                                              CellRight's  medical  director,  a  licensed  physician,  performs
                                                              an  extensive  medical  review  of  the  donor's  medical/social
                                                              history to determine• eligibility.  Only donors whose screening,
                                                              serologic, and microbiologic tests meet or exceed the current
                                                              standards  established  by the  Food and  Drug Administration
                                                              (FDA)  and  the American Association of 11ssue Banks {AATB)
                                                              are accepted for  ransplantation.
                                                             ConCelltrate 8   100  is  indicated  for  homologous  use  ror  the
                                                             lreatment of surgically created or traumatic skeletal defects.
                                                                                                        -


                                                                           FEATURES AND BENEF TS

                                                                         Osteoinductive - each lot is assayed

                                                                                 Osteoconduclive


                                                                   I Sterile• Sterility Assurance  evel (SAL) of 10-fi

                                                                                 Five year shelf lite

                                                                          100% bone - no additional carrier

                                                                      Ambient storage and shipping lemperatures

                                                                                 Resists irngalion

                                                                                 Available in a jar




                                                                                                   SIZ  S AVAILABLE
           ConCelltrate" 100 may be used in surgical procedures
                                                                                                  Jar
           including:     Spine             Reco nslruclion
                                                                                                   1  0 cc
                          Neuro             Foot & Ankle                                          2.5 CIC
                          Orthopedics       Dental                                                5_0 cc
                                                                                                   10 cc














         AKT.001  C 09/2016
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