FDA.reportPublic FDA data

Saline-filled breast implant, internally-structured

Definition
A sterile implantable device designed to reconstruct or augment the breast that is composed of a smooth silicone outer shell containing a nested silicone-shell support structure, creating multiple nested lumens inflated with sterile isotonic saline to the desired size. Movement of saline between the lumens is possible through slits and tempered by baffles; the implant has separate fill valves for each lumen and is typically filled with saline before or during the implant procedure.
GUDID devices
27
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850034511092Puregraft Serene Breast ImplantBimini Technologies LLC210CC2024-03-28
00850034511283Puregraft Serene Breast ImplantBimini Technologies LLC270CC2024-03-28
00850034511368Puregraft Serene Breast ImplantBimini Technologies LLC300CC2024-03-28
00850034511436Puregraft Serene Breast ImplantBimini Technologies LLC335CC2024-03-28
00850034511641Puregraft Serene Breast ImplantBimini Technologies LLC370CC2024-03-28
00850034511665Puregraft Serene Breast ImplantBimini Technologies LLC405CC2024-03-28
00850034511689Puregraft Serene Breast ImplantBimini Technologies LLC440CC2024-03-28
00850034511764Puregraft Serene Breast ImplantBimini Technologies LLC475CC2024-03-28
00850034511788Puregraft Serene Breast ImplantBimini Technologies LLC515CC2024-03-28
00850034511818Puregraft Serene Breast ImplantBimini Technologies LLC555CC2024-03-28
00850034511856Puregraft Serene Breast ImplantBimini Technologies LLC595CC2024-03-28
00850034511870Puregraft Serene Breast ImplantBimini Technologies LLC635CC2024-03-28
00850034511917Puregraft Serene Breast ImplantBimini Technologies LLC675CC2024-03-28
00850034511153Puregraft Serene Breast ImplantBimini Technologies LLC210CC2024-03-28
00850034511337Puregraft Serene Breast ImplantBimini Technologies LLC270CC2024-03-28
00850034511399Puregraft Serene Breast ImplantBimini Technologies LLC300CC2024-03-28
00850034511627Puregraft Serene Breast ImplantBimini Technologies LLC350CC2024-03-28
00850034511658Puregraft Serene Breast ImplantBimini Technologies LLC370CC2024-03-28
00850034511672Puregraft Serene Breast ImplantBimini Technologies LLC405CC2024-03-28
00850034511757Puregraft Serene Breast ImplantBimini Technologies LLC440CC2024-03-28
00850034511771Puregraft Serene Breast ImplantBimini Technologies LLC475CC2024-03-28
00850034511801Puregraft Serene Breast ImplantBimini Technologies LLC515CC2024-03-28
00850034511825Puregraft Serene Breast ImplantBimini Technologies LLC555CC2024-03-28
00850034511863Puregraft Serene Breast ImplantBimini Technologies LLC595CC2024-03-28
00850034511894Puregraft Serene Breast ImplantBimini Technologies LLC635CC2024-03-28
00850034511924Puregraft Serene Breast ImplantBimini Technologies LLC675CC2024-03-28
00850034511931Puregraft Serene Breast ImplantBimini Technologies LLC240CC2024-03-28