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Puregraft Serene Breast Implant

Saline Breast Implant

Details

Device typeSaline-filled breast implant, internally-structured: 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.

FDA categoryProsthesis, Breast, Inflatable, Internal, Saline

Device ID00850034511931

AvailabilityPrescription

Single useYes

SterileYes

MRI safetyLabeling does not contain MRI Safety Information

Total Volume240 Milliliter

Contact

No contact is listed for this device.

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