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AmGraft single and dual layer amniotic membrane allograft product packaging box

AmGraft™ – Single Layer Amniotic Membrane Allograft

AmGraft Amniotic Membrane Allograft — Single Layer

AmGraft™ is a single-layer human amniotic membrane allograft processed using Amnion’s proprietary AmnioCleanse™ tissue purification technology. It is minimally manipulated and intended for homologous use, retaining the essential biostructure found in human amnion.

Placement and Handling

When placed over the wound or surgical site, AmGraft™ serves as a protective biological covering, conforming to the site. It can be sutured or placed as a covering. For applications calling for a thicker construct, the dual-layer AmGraft™ Plus is made to order in the same size range.

Storage

AmGraft™ is terminally sterilized using electron-beam technology, stored at room temperature (15–30°C), and carries a five-year shelf life. No cold chain, no thawing, and no reconstitution are required.

Quality & Safety Standards

Every AmGraft™ allograft is procured and processed according to standards established by the American Association of Tissue Banks (AATB) and the United States Food and Drug Administration (FDA). All tissues are recovered under full informed consent from planned C-section donors. Amnion is an ISO 13485-certified and AATB-accredited tissue bank. Contact our team to learn more.

Sizes other than those listed are made to order. Request a quote for a custom size.

Product Standards

AmGraft™ allografts are procured and processed according to standards established by the American Association of Tissue Banks (AATB) and the United States Food and Drug Administration (FDA). All tissues are recovered under full informed consent of the planned C-section donors (represented by the mothers of the newborn children). The donors have consented to transfer of the allografts to third parties. A thorough medical exam and social history of the donor is also obtained, including detailed family history.

Tissue Safety

The Donor is Screened for:

  • HBsAg: Hepatitis B Surface Antigen
  • HBcAb: Hepatitis B Core Total Antibody (IgG and IgM)
  • HCVAb: Hepatitis C Antibody
  • HIV 1/2/Ab: Human Immunodeficiency Virus Types 1/2 and O Antibody
  • HCV NAT: Hepatitis C Virus
  • HIV NAT: Human Immunodeficiency Virus
  • HBV NAT: Hepatitis B Virus
  • RPR/STS or Equivalent: Syphilis
  • West Nile Virus (WNV) Assay
  • Along with other clinical and physical evidence, which is relevant and would aid in donor eligibility determination.

All test results are reviewed prior to release of the tissue.

Tissue Safety Image