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The GMD Universal Urinary Incontinence Sling-1011 is a suburethral sling indicated for use in women for treatment of stress urinary incontinence (SUI) resulting from either urethral hypermobility and/or intrinsic sphincter deficiency. The mesh is placed transvaginally using reusable introducers (sold separately) either through a transobturator or retropubic approach. The use of the device in males and children under 18 years of age is not supported by clinical studies.

The GMD Universal Urinary Incontinence Sling™-1011 is a sterile, single use device for the treatment of female Stress Urinary Incontinence. The Universal Urinary Incontinence Sling™ -1011 is comprised of the same polypropylene knitted mesh as its Model 1010 and Model 1012 predicates, protected by the same disposable polypropylene sheath as its Model 1012 predicate with a disposable low density polypropylene universal sleeve at each end made of the same material and similar in design to the sleeve of its Model 1010 predicate, for attachment of the sling to GMD's reusable trocars (sold separately). Similar to both predicates, the Universal Urinary Incontinence Sling™ -- 1011 is used for inside-out / bottom-up and outside-in / top-down approaches. Similar to both predicates, the method of placement and surgical approach chosen by the physician should be appropriate for the patient's diagnosis and anatomy.

The GMD Universal Sling is indicated for use in women as a suburethral sling for the treatment of stress urinary incontinence (SUI) resulting from either urethral hypermobility and/or intrinsic sphincter deficiency.

The GMD Universal Sling System ™ – is a sterile, single use device for the treatment of female stress urinary incontinence. The Universal Sling is comprised of a polypropylene knitted mesh protected by a disposable polyurethane sheath with a disposable low density polypropylene universal sleeve at each end for attachment of the sling to GMD's single use or reusable trocars (sold separately). The universal sleeve has three trocar insertion points, the distal and proximal trocar insertion points are for inside-out / bottom-up approaches and a sleeve end trocar insertion point is for outside-in / top-down approaches. The method of placement and surgical approach chosen by the physician should be appropriate for the patient's diagnosis and anatomy.

The Universal Surgical Mesh is intended for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Universal Surgical Mesh is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh (ETHICON, INC). The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue in-growth. Universal Surgical Mesh in knitted by a process that interlinks each fiber junction and provides for elasticity in both directions. This construction permits the mesh to be cut into any desired shape or size without unraveling. The bi-directional elastic property allows adaptation to various stresses encountered in the body.

The GMD Circumcision Clamp is intended to be used in the medical procedure of circumferential excision of the foreskin or prepuce skin at or near the level of coronal sulcus, with minimal amount of preputial skin remaining.

The GMD Circumcision Clamp is a stainless steel reusable medical device intended to be used in circumcision procedures. The GMD Circumcision clamp will be sold non-Sterile.