CLINICAL RESOURCES
Safety, Licenses & Tracking
Premium quality bone allografts — backed by rigorous donor screening, independent laboratory testing, and industry-leading sterilization protocols.
Our Tissue Bank Quality Systems
meet or exceed all:
SECTION 1
Donor Eligibility Screening
- Strict quality systems and validated processes ensure patient safety from the initial donor consultation to the surgeon's transplantation of our allograft.
- Comprehensive medical and social histories are thoroughly reviewed by qualified personnel on every donor.
- All donations are reviewed for eligibility by a qualified and trained Medical Director.
- Recovery technicians are trained by their respective agencies, receiving continuing education to assure consistent knowledge and application of our strict donor acceptance standards.
- All our cadaveric tissue donations come from not-for-profit OPOs and recovery agencies.
SECTION 3
Bone Allograft Sterilization
- Our allografts are terminally sterilized via low dose gamma irradiation.
- Gamma irradiation dosage was determined by performing a VDMAX validation, and is verified on a quarterly basis.
- Our allografts have a Sterility Assurance Level (SAL) of 10-6.
SECTION 2
Bone Allograft Testing
- All tissue and blood samples are tested for infectious diseases by a CLIA Certified Lab.
- Tissue is thoroughly tested for AIDS, using Nucleic Acid Testing (NAT by TMA), the newest and most reliable test to confirm the absence of HIV and HCV.
- As an accredited member of the American Association of Tissue Banks (AATB), our tissue bank's testing and processing of donated tissue meet or exceed all FDA and AATB regulations, and are tested using FDA-required test kits.
COMPREHENSIVE TESTING PANEL
LICENSES & DOCUMENTATION
Regulatory Documentation
Surgical Esthetics and our tissue procurement and processing partners are proudly licensed and registered with all applicable Federal and State Regulatory Agencies.
PRODUCT TRACKING
Track Your Products
Use the links below to track your tissue products by serial number.
GingiDerm Tracking
Track GingiDerm tissue allograft products
TRACK →
AmnioGain Sheet Tracking
Track AmnioGain Sheet amnion-chorion products
TRACK →
AmnioGain Liquid Tracking
Track AmnioGain Liquid amnion-chorion products
TRACK →
BONE ALLOGRAFT PRODUCTS
For allograft bone products, please follow the instructions on the Package Insert. Each package includes a form to fill out, along with serialized stickers to attach to the form. This should be mailed to the address indicated on the form.
Need help? Contact regulatory@surgicalesthetics.com →