68cf9f39-6f43-4347-8782-9ad5a1494854UpdatePublished42023-07-182015-10-12In Commercial DistributionB049ACP51R0PrimaryHIBCCGluteal ImplantACP 5-1 RACP 5-1 R058759296Hanson Medical, Inc.1Non-sterile, silicone, gluteal implant, right.falsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse1(800)771-2215erik@hansonmedical.comK03080900045230Silicone-block tissue reconstructive materialA non-sterile, solid chunk of silicone elastomer typically modified to suit the patient anatomy and implanted, after sterilization, for tissue reconstruction during a surgical procedure. The device is typically available as a cube with a rectangular cross-section or with curved surfaces. It may be carved or trimmed into different sizes and shapes for various reconstructive or cosmetic plastic surgery procedures that involve soft-tissue or bone augmentation, or the formation of prosthetic implants (e.g., chin or malar). This is a single-use device.trueActiveMIBElastomer, Silicone BlockfalsetrueMoist Heat or Steam Sterilization