Before use, physicians should review complete risk information and essential prescribing information which can be found in the
Instructions for Use
ALLODERM SELECT™ Regenerative Tissue Matrix Ready to Use (referred to herein as “ALLODERM SELECT™ RTM Ready to Use”) is donated allograft human dermis, processed to remove cells while preserving biologic components and structure of the dermal matrix. ALLODERM SELECT™ RTM Ready To Use is white to buff colored and is uniform in appearance. All labeled dimensions are at nominal values only.
INDICATIONS FOR USE
ALLODERM SELECT™ RTM Ready To Use is intended to be used for repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument. Each package of ALLODERM SELECT™ RTM Ready To Use is intended for use in one patient, on a single occasion.
ALLODERM SELECT™ RTM Ready To Use is not indicated for use as a dural substitute.
ALLODERM SELECT™ RTM Ready To Use is not intended for use in veterinary applications.
ALLODERM SELECT™ RTM Ready To Use is contraindicated for use in any patient who is sensitive to any of the antibiotics listed on the package or Polysorbate 20.
Processing of the tissue, laboratory testing, and careful donor screening minimize the risk of the donor tissue transmitting disease to the recipient patient. As with any processed donor tissue, ALLODERM SELECT™ RTM Ready To Use is not guaranteed to be free of all pathogens. No long-term studies have been conducted to evaluate the carcinogenic or mutagenic potential or reproductive impact of the clinical application of ALLODERM SELECT™ RTM Ready To Use.
DO NOT re-sterilize ALLODERM SELECT™ RTM Ready To Use.
Discard all open and unused portions of the product. Once a package or container seal has been compromised, the tissue shall be either transplanted, if appropriate, or otherwise discarded.
DO NOT use if the pouch is opened or damaged.
DO NOT use product after expiration date noted on the label.
Transfer ALLODERM SELECT™ RTM Ready To Use from the foil pouch aseptically.
DO NOT place the foil pouch in the sterile field.
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 Ready To Use as such conditions may compromise successful clinical outcome.
Whenever clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures should be taken.
ALLODERM SELECT™ RTM Ready To Use has a distinct basement membrane (upper) and dermal surface (lower). (See ORIENTATION.) When applied as an implant, it is recommended that the dermal side be placed against the most vascular tissue.