Device typeSilicone gel-filled breast implant, smooth-surface: An implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber shell, made of polysiloxane(s), with a single lumen filled with a fixed amount of silicone gel; the shell surface is smooth. The implant may vary in shape, profile, volume and shell thickness.
FDA categoryProsthesis, breast, noninflatable, internal, silicone gel-filled
Device ID00081317000426
Catalog number350-2004BC
AvailabilityPrescription
Single useYes
SterileYes
LatexNot made with natural rubber latex
MRI safetyLabeling does not contain MRI Safety Information