The implant is regulated as 361 human cell and tissue product (HCT/Ps) as defined in USFDA 21 CFR 1271 and is restricted to homologous use for the repair, replacement, reconstruction, or augmentation of soft tissue by a qualified healthcare professional (e.g., physician). The implant is provided sterile and requires rehydration prior to use.
PROCESSING AND STERILIZATION
The implant was processed in a controlled environment from a single donor. Microbial testing was performed where appropriate, and results met a documented acceptance criterion. The implant was released for transplantation based on the donor eligibility determination and a review of processing records.
The Tutoplast® tissue sterilization process includes meticulous cleaning and gentle solvent dehydration of tissue. The process inactivates or removes potential pathogens, gently removes unwanted materials, such as cells, antigens and viruses and allows the implant to be stored at room temperature. As part of the Tutoplast® tissue sterilization process, low dose gamma irradiation is applied terminally to the dry implant to achieve a minimum sterility assurance level (SAL) of 10-6. Trace amounts of manufacturing residuals may remain after processing (acetic acid, acetone, hydrogen peroxide and sodium hydroxide).
STORAGE & SHIPPING
- Storage Conditions
- Shipping Conditions
ORDERING INFORMATION – Q4345
- Code Description
- MDRM-11 Derm-Maxx® Dermal Matrix 1x1cm
- MDRM-22 Derm-Maxx® Dermal Matrix 2x2cm
- MDRM-24 Derm-Maxx® Dermal Matrix 2x4cm
- MDRM-44 Derm-Maxx® Dermal Matrix 4x4cm
- MDRM-48 Derm-Maxx® Dermal Matrix 4x8cm
- MDRM-510 Derm-Maxx® Dermal Matrix 5x10cm
- MDRMF-11 Derm-Maxx® Dermal Matrix, Fenestrated 1x1cm
- MDRMF-22 Derm-Maxx® Dermal Matrix, Fenestrated 2x2cm
- MDRMF-24 Derm-Maxx® Dermal Matrix Fenestrated 2x4cm
- MDRMF-44 Derm-Maxx® Dermal Matrix Fenestrated 4x4cm
- MDRMF-48 Derm-Maxx® Dermal Matrix Fenestrated 4x8cm
- MDRMF-510 Derm-Maxx® Dermal Matrix Fenestrated 5x10cm
REFERENCES
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Advanced Synthetics
About Royal
Royal is a pioneering leader in orthobiologic and wound care research and development. Royal’s commitment lies in delivering top-tier, innovative biologic solutions that enhance the healing process and improve patients' quality of life. Royal places patient well-being at the center of its mission, offering exceptional solutions to address a variety of complex needs.
At Royal, our mission is driven by patient-centered care, innovation and excellence, and integrity and compassion. Royal provides a comprehensive array of products tailored to meet the varied needs of the orthobiologic and wound care industry.
As a rapidly expanding force in the industry, Royal is continuously developing and launching new products and solutions that set benchmarks for quality, effectiveness, and patient outcomes. Royal’s commitment to research and innovation keeps it at the forefront of the industry, helping to shape the future of healthcare and improving lives.