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Rocky Mountain Tissue Bank: Allogenic Bone Grafts

Established in 1980, Rocky Mountain Tissue Bank is an independent non-profit organization based in Colorado, USA. We produce irradiated allogenic cancellous bone and marrow for human transplantation, approved by FDA cGTP and ISO 9001-2008 certified.

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Rocky Mountain Tissue Bank: Allogenic Bone Grafts

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  1. A Non Profit Organisation based in Colorado- USA., • Founded in 1980 • Founded by Dr.William H Hiatt DDS a Periodontist. • Independent Tissue Processing Company without any affiliation to any other tissue bank • Develops & Produce Irradiated allogenic cancellous bone and marrow for human transplantation. • Approved by FDA Current Good Practices (cGTP) 21CFR 1271, the requirement of American Association of Tissue Banks “ Standard for Tissue Banking”

  2. GLOBAL REGISTRATIONS/ACCREDITATION Approval # OMB No:0910-0543 American Association of Tissue Bank Certificate # 100156 First Tissue Bank to obtain ISO 9001-2008 certificate to distribute to European Union. Korean Approvals

  3. Rocky Mountain Tissue Bank Grafts: RMTB RMTB grafts are "Donated Human Tissue" which have been prepared from a donor that has met the donor suitability criteria. Suitability is based on a documented Medical Director review of screening and testing records. These records include but are not limited to donor profile, informed consent, medical/social history, procurement documentation, microbiological testing, serology testing, hospital records (if applicable), autopsy report (if applicable), as well as all processing records. All Donors have been screened and shown negative for the presence of active infectious disease, malignancies, degenerative neurological disease of unknown etiology, and diseases of unknown etiology. Blood samples have been tested for relevant communicable diseases and shown negative for HIV 1 & 2, Hepatitis B Surface Antigen, Hepatitis B core (total). Hepatitis C antibody, HTLV 1 & 2, syphilis (RPR), nucleic acid test (NAT) for HIV 1 & HCV. Communicable disease testing was performed by a laboratory registered with the FDA to perform donor testing and certified to perform such testing on human specimens in accordance with the Clinical Laboratory Improvements Amendments of 1998 (CLIA) and 42 CFR part 493.

  4. Indications: -Sinus Augmentation-Sinus Lift-On-Lay Grafts-Periodontal Defects-Segmental Osteotomies - Tunnel Grafting - Socket Preservation -  Block Grafting Dental Procedures by Dr. Stuart Orton-Jones - Irradiated Bone Grafting Dental procedures by Dr. David Resnick - RMTB Bone Block Grafting To View Surgical Videos Click Above Links with internet connection Our Processing provides you the greatest assurance of allograft quality and safety.

  5. Clinical Updates on Allografts Socket Preservation and Sinus Augmentation Using a Medical Grade Calcium Sulfate Hemihydrate and Mineralized Irradiated Cancellous Bone Allograft Composite Robert Bagoff, DDS  Sachin Mamidwar, MS, MBBS Ioana Chesnoiu-Matei, DDS, MS John L. Ricci, PhD Harold Alexander, PhD Nick M. Tovar, PhD http://www.joionline.org/doi/abs/10.1563/AAID-JOI-D-10-00178 https://onlinelibrary.wiley.com/doi/abs/10.1902/jop.2011.100601 De Novo Bone Formation After the Sinus Lift Procedure Albert M. Price Martha Nunn Frank G. Oppenheim Thomas E. Van Dyke Click Above Links with internet connection

  6. Irradiated Allogenic Cancellous Bone and Marrow Graft Material RM·CanPar (Cancellous Bone Particulate) CANCELLOUS PARTICULATE VIALSIrradiated Allogenic Cancellous Bone and Marrow ParticulateRandomly sized. • RM-Canpar 0.25mg • RM-Canpar 0.50mg • RM-Canpar 1.0 gm • RM-Canpar 2.0 gm • RM-Canpar 3.0 gm - Also available as RM-Corpar Cancellous Particulate Vials with Cortical Bones with same above quantities packing.

  7. Irradiated Allogenic Cancellous Bone and Marrow Graft Material CORTICAL / CANCELLOUS “BONE BLOCKS”Irradiated  Allogenic Cortical/Cancellous Bone Blocks D W L D W L 5 x 10 x 10 mm RM·BB 10 x 10 x10 mm RM·BB 5 x 10 x 20 mm RM·BB 10 x 10 x 20 mm RM·BB 5 x 10 x 30 mm RM·BB 10 x 10 x 30 mm RM·BB D = Depth W = Width L = Length

  8. Irradiated Allogenic Cancellous Bone and Marrow Graft Material RM·BB (Bone Block) CORTICAL PARTICULATE VIALS- “BONE BLOCKS”Irradiated Allogenic Crushed Cortical ParticulateRandomly sized 2-3 mm. RM·CorPar 0.5 g RM·CorPar 1 g

  9. Instructions for Use & Storage with Compliance – Mandatory Requirements 1. In the Rocky Mountain Tissue Bank processing, protocol, every effort is made to ensure the safety of our tissue. However, current technologies may not preclude the transmission of infectious agents. 2. The use of this tissue is limited to hospitals, physicians, dentists or other qualified medical professionals. 3. Allograft has been irradiated with betweeen 25 kGy and 38 kGy of irradiation. 4. Do Not Re-sterilize. 5. Store at Room Temperature. 6. It is the responsibility of the transplant facility and/or the clinician to maintain the allograft in the appropriate storage conditions prior to transplantation. 7. The Particulate grafts transport tube should be opened and inner sterilized vial placed in sterile surgical field; or the Bone Block outer pouch is opened and inner pouch is placed in sterile field. 8. Once the container seal has been compromised, the tissue shall be either transplanted or discarded. 9. No Special Handling is required. 10. No additional preparation is necessary for transplantation, such as diluting or reconstitution. 11. For Single Patient Use Only. **ADVERSE OUTCOMES ATTRIBUTED TO THE TISSUE MUST BE REPORTED PROMPTLY TO ROCKY MOUNTAIN TISSUE BANK. ***A PATIENT TRACKING FORM ACCOMPANIES EVERY TISSUE GRAFT, COMPLETE AND RETURN IT TO ROCKY MOUNTAIN TISSUE BANK IMMEDIATELY AFTER TISSUE IS TRANSPLANTED. ****IT IS THE RESPONSIBILITY OF THE TRANSPLANT FACILITY AND THE CLINICIAN TO MAINTAIN RECIPIENT RECORDS FOR THE PURPOSE OF POST-TRANSPLANT TRACING.

  10. Marks Biotech Inc., 104/5, Second Floor, S-1, The Brown Building, Radha Avenue 6th Street, Valasaravakkam, Chennai +91 98198 93250 or +91 44 48593250 Email : info@marksbiotech.com www.marksbiotech.com Mani Krishnan +91 98198 93250

  11. For more information and communication write back to : mani.krishnan@marksbiotech.com Or call +91 98198 93250

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