CentaFlex® tissue procurement and processing practices meet high safety standards.
Tissue used in processing CentaFlex®:
- Has been procured, processed, and tested in accordance with standards established by the American Association of Blood Banks (AABB) and the United States Food and Drug Administration (FDA)
- Passed safety testing for cytotoxicity, hemolysis, irritation, endotoxins, and pyrogenicity
- Utilizes a barcode tracking system for optimal safety monitoring and to enhance patient and practitioner confidence
Donor screening and testing
- Maternal health screening, including social history
- Family medical history
- Each donor has been determined by trained, qualified, and responsible personnel to meet the screening and testing requirements of 21 CFR Part 1271 Subpart C: Donor Eligibility.
Registrations and Accreditations
Celularity is registered with the FDA as a tissue establishment and accredited by the AABB.
INDICATIONS FOR USE
CentaFlex is an allograft used as a barrier or wrap to cushion and protect the surgical site and support wound management. It is intended for use as a biological membrane covering. As a barrier membrane, CentaFlex is intended to protect the underlying tissue. Indications include, but are not limited to, surgical covering, wrap or barrier.
CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS
CentaFlex® is contraindicated in patients with a known hyper-sensitivity to CentraFlex®.
If a patient has an adverse reaction related to the use of CentaFlex®, immediately discontinue its use. CentaFlex® should not be used on clinically infected wounds.
The pouch contents are sterile if the pouch is unopened and undamaged. Do not use if package seal is broken. Discard material if mishandling has caused possible damage or contamination. Do not resterilize.
CentaFlex® must be used prior to the expiration date on the product pouch.
CentaFlex® should not be used together with a collagenase product on the wound.
For product information or adverse reaction reporting, telephone 1-844-963-2273. Please refer to the CentaFlex® Package Insert for complete product information.