![]() ![]() To discuss setting up an account with us, please contact the Providence Branch at (401) 780-8939 To discuss setting up an account with us, please contact the Orlando Branch at (407) 290-1383 To discuss setting up an account with us, please contact the Miami Branch at (305) 635-6421 To discuss setting up an account with us, please contact the Manchester Branch at (603) 894-0082 To discuss setting up an account with us, please contact the Jacksonville Branch at (904) 398-3090 To discuss setting up an account with us, please contact the Greenville Branch at (864) 288-0552 To discuss setting up an account with us, please contact the Albany Branch at (518) 464-0573 To report an adverse reaction, please call BioHorizons Customer Care at 1. discuss setting up an account with us, please contact the Beltsville Branch at (301)419-0033 Potential adverse events which may result from surgical procedures associated with the implant of a tissue graft include, but are not limited to the following: wound or systemic infection dehiscence hypersensitive, allergic or other immune response and sloughing or failure of the graft.įor more information, please see the Instructions for Use (IFU) for ALLODERM SELECT™ RTM and ALLODERM SELECT GBR™ RTM available at or call 1.800.678.1605 for a copy of the IFU. Please see the Instructions for Use (IFU) for more information on patient/product selection and surgical procedures involving tissue implantation before using ALLODERM SELECT™ RTM. Certain considerations should be made to reduce the risk of adverse events when performing surgical procedures using a tissue graft. Use of this product is limited to specific health professionals (e.g., physicians, dentists, and/or podiatrists). If any hair is visible, remove using aseptic technique before implantation.ĪLLODERM SELECT™ RTM should be hydrated and moist when the package is opened. Soak the tissue for a minimum of 2 minutes using a sterile basin and room temperature sterile saline or room temperature sterile lactated Ringer’s solution to cover the tissue. When applied as an implant, it is recommended that the dermal side be placed against the most vascular tissue. ![]() Whenever clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures should be taken.ĪLLODERM SELECT™ RTM has a distinct basement membrane (upper) and dermal surface (lower). Poor general medical condition or any pathology that would limit the blood supply and compromise healing should be considered when selecting patients for implanting ALLODERM SELECT™ RTM as such conditions may compromise successful clinical outcome. DO NOT place the foil pouch in the sterile field. Transfer ALLODERM SELECT™ RTM from the foil pouch aseptically. DO NOT use after the expiration date noted on the label. DO NOT use if the temperature monitoring device does not display "OK". DO NOT use if the seal is broken or compromised. DO NOT use if the foil pouch is opened or damaged. Once a package or container seal has been compromised, the tissue shall be either transplanted, if appropriate, or otherwise discarded. Discard all open and unused portions of the product in accordance with standard medical practice and institutional protocols for disposal of human tissue. DO NOT reuse once the tissue graft has been removed from the packaging and/or is in contact with a patient. No long-term studies have been conducted to evaluate the carcinogenic or mutagenic potential or reproductive impact of the clinical application of ALLODERM SELECTTM RTM.ĭO NOT re-sterilize ALLODERM SELECT™ RTM. As with any processed donor tissue, ALLODERM SELECT™ RTM is not guaranteed to be free of all pathogens. Processing of the tissue, laboratory testing, and careful donor screening minimize the risk of the donor tissue transmitting disease to the recipient patient. ALLODERM SELECT™ RTM is not indicated for use as a dural substitute or intended for use in veterinary applications.ĪLLODERM SELECT™ RTM should not be used in patients with a known sensitivity to any of the antibiotics listed on the package and/or Polysorbate 20. This product is intended for one patient on a single occasion. Indications and Important Safety InformationĪLLODERM SELECT™ Regenerative Tissue Matrix (ALLODERM SELECT™ RTM refers to both ALLODERM SELECT™ RTM and ALLODERM SELECT GBR™ RTM products) is intended to be used for repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument including gingival. ALLODERM SELECT™ Regenerative Tissue MatrixĪLLODERM SELECT GBR™ Regenerative Tissue Matrix ![]()
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