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AlloX2 Tissue Expanders are intended for temporary (less than six months) subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstructions following mastectomy, to aid in the treatment of underdeveloped breasts and to aid in treatment of soft tissue deformities. Additionally, the AlloX2 Tissue Expanders contain a silicone drain component which allows access to and drainage of latent fluids from the periprosthetic space. This drain component does nort-term, immediate, intraoperatively placed drains.

The AlloX2 Tissue Expanders are constructed as a unit from silicone elastomer and consist of a smooth or textured expansion envelope with an integral magnetic injection port. Specialty Surgical Products is proposing that an integral or remote (connected by tubing) drain port be integrated into the predicate device to facilitate the drainage of fluid in the periprosthetic pocket. The port design and magnetic technology/concept are the same as those of the predicate injection ports. The principles of operation of the subject device methodology are identical to that of the primary predicate Silicone Tissue Expander and the additional predicate Closed Wound Drain.

The mammary sizer is designed for single use, temporary intraoperative placement in a surgically created pocket. The sizer is used to evaluate the appropriate mammary prosthesis volume for each patient prior to implantation of a mammary prosthesis.

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The Virilis Penile Prostheses are intended for implantation into the corpora cavernosa of the penis in patients who are diagnosed as having erectile dysfunction. The prosthesis is implanted to provid adequate penile rigidity for vaginal penetration.

Virilis Penile Prostheses

The Specialty Surgical Products Mammary Sizer is intended to assist in evaluation of the appropriate mammary prosthesis volume for each patient prior to implantation.

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Specialty Surgical Products Sterile Silicone Wound Covers are intended for external use in short term applications related to wound treatment by temporarily covering traumatic areas where primary closure attempts must be abandoned in favor of a staged repair.

Sterile Silicone External Wound Covers

Silicone Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts, and to aid in the treatment of soft tissue deformities.

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Specialty Surgical Products Silicone Sheeting is intended for a variety of medical purposes both in short term and long term applications. For short term applications for use are: for nasal splinting, wound dressings, managment of hypertrophic or keloid scarring, to prevent soft tissue fibrosis or bony ankylosis following surgical correction of trismus, temporary joint spacers and laboratory uses. For longterm application the indications for use are: for nasal septal repair, orbital floor reconstruction, tympanic membrane repair, dialysis shunt anchoring, duramater repair of omphalocele, for lengthening extraocular muscles in select cases of strabismus, as a protective sheathing to help facilitate neural regeneration and tendon anastomosis, as a protective sheathing to help facilitate osteogenesis, guided tissue regeneration between teeth and gingival margin, or external ear canal for example

Silicone Elastomer Sheeting

The Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process.

Silicone Blocks

Silicone Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts, and to aid in the treatment of soft tissue deformities.

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The catheter is designed to aid in controlling nasal hemorrhage due to trauma from injury. The device may r he baneler is a postoperative nasal packing following various intranasal surgical procedures, including septoplasty and rhinoplasty procedures.

Disposable Sillicone Epistaxis Catheter