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Phamedica PHA S1 Spinal System is intended for posterior non-cervical pedicle fixation of Thoracic, Lumbar, Sacral/ Iliac Spine in skeletally mature patients, as an adjunct to fusion using autogeneous bone graft or all of the following indications: · Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) - · Spondylolisthesis - · Trauma (i.e., fracture or dislocation) - · Spinal Stenosis - · Curvatures (i.e., scoliosis, kyphosis, and/or lordosis) - Tumor - Pseudoarthrosis - · Failed previous fusion in skeletally mature patients.

Phamedica PHA S1 Spinal Fixation system consists of Poly Axial screws, Mono Axial Screws, Poly Axial and Mono Axial Reduction Screws, Rods, Set Screws, Transverse and Offset connectors made from Titanium Alloy Ti6AL4V which can be variously assembled for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine.

The FlowMedica Benephit® Infusion Systems are intended to facilitate targeted renal therapy, or TRT®, the delivery of physician-specified agents to the kidneys via the renal arteries. The Benephit® Infusion Systems are indicated for use in patients undergoing medical, interventional, or surgical procedures, where the procedure carries an elevated risk of iatrogenic kidney injury for the patient. The Benephit® Infusion Systems are also indicated to facilitate TRT® in patients who have demonstrated symptoms of acute kidney injury, and in whom arterial catheterization for TRT® is feasible.

The Benephit® family of infusion systems comprises the Benephit® CV, Benephit® PV, Benephit® PVMini, Benephit® PVSolo, and Benephit® XT systems. Each system includes a bifurcated infusion catheter and a vascular introducer sheath with dilator. Each Benephit® Infusion System consists of a bifurcated infusion catheter and a vascular introducer sheath with dilator. The bifurcated infusion catheter in each of the Benephit® systems is a single-lumen infusion catheter with a bifurcated distal end that allows access to two locations (e.g., two renal arteries) for infusion simultaneously. Each system's introducer sheath is a PTFE-lined, coil reinforced polymer sheath with matching radiopaque dilator. The Benephit® CV system comprises a 2.4 Fr. bifurcated infusion catheter, utilizing a nitinol hypo tube shaft, and an 8 Fr. compatible introducer sheath with a unique Y-hub design. The Benephit® PV, PVMini, PVSolo, and XT systems comprise a 4.8 Fr. bifurcated catheter utilizing a braid reinforced polymer shaft and a 5 Fr. compatible introducer sheath with a standard single hemostasis valve configuration.

The FlowMedica Benephit™ △ Bifurcated Infusion Catheter is intended for the infusion of fluids into the peripheral vasculature including but not limited to the renal arteries. The FlowMedica Benephit™ Δ 5Fr. Introducer Sheath is intended to facilitate the entry of interventional and diagnostic devices into the human vasculature.

Benephit™ Δ Infusion System (Benephit™ Δ Bifurcated Infusion Catheter & Benephit™ Δ 5Fr. Introducer Sheath)

NanOss Bone Void Filler is intended only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

NanOss Bone Void Filler is an osteoconductive, resorbable, calcium phosphate implant for use as a bone graft substitute or bone void filler. The device consists of prefabricated cylindrical calcium phosphate pellets. The device is radiopaque and is presterilized for single use. The nanocrystalline processing of the material results in sintered hydroxyapatite pellets that are translucent and uniform in density and strength.

The ULTRA SYSTEM is a reusable sterilization container system intended to allow sterilization of enclosed surgical instruments by health care providers in ethylene oxide sterilizers and to maintain sterility of the enclosed instruments until they are used. Baskets are used with the container to facilitate placement of the enclosed surgical instruments.

The ULTRA SYSTEM is a reusable sterilization container system.

The ULTRA SYSTEM SP™ is a reusable sterilization container system intended to allow sterilization of enclosed surgical instruments by health care providers in the STERRAD™ 50 and 100S Sterilizers and to maintain sterility of the enclosed instruments until they are used. Baskets are used with the container to feciliate placement of the enclosed surgical instruments. The maximum load is 8.35 pounds in the STERRAD™ 50 or 16.70 pounds in the STERRAD™ 100S. A maximum of Junens may be sterilized in each load.

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Infusion of physician-specified agents in the peripheral vasculature including but not limited to the renal arteries. The FlowMedica Introducer Sheath is intended to facilitate the entry of interventional and diagnostic devices into the human vasculature.

The FlowMedica Bifurcated Infusion System consists of the FlowMedica Bifurcated Infusion Catheter and the FlowMedica Introducer Sheath. The FlowMedica Bifurcated Infusion System consists of the Bifurcated Infusion Catheter and the Introducer Sheath. It is intended for single-use only and is sterilized using ethylene oxide gas. The Bifurcated Infusion Catheter functions by selectively delivering physician-specified agents directly to the peripheral vasculature. The Bifurcated Infusion Catheter contains a 77cm working length shaft/infusion lumen. It is bifurcated at the distal end, which is comprised of two identical metal-supported and braided polymer branches. The Introducer Sheath provides for the introduction of two interventional devices through a single vessel access site, allowing for the introduction of the Bifurcated Infusion Catheter and the introduction of a standard coronary guiding or diagnostic catheter as may be required for a catheterization procedure. The Introducer Sheath, available in four lengths, is a polymer and metal coil reinforced sheath with two insertion ports in its integral Y hub assembly. The ports contain a hemostasis valve, designed for a 6Fr diagnostic or guiding catheter, and Touhy Borst valve used for the Bifurcated Infusion Catheter. A vessel diffator is supplied with the Introducer Sheath. The FlowMedica Bifurcated Infusion Catheter is designed for use only with the FlowMedica Introducer Sheath. Each component is packaged separately and may be ordered and shipped separately; however, the Instructions for Use included with the Bifurcated Infusion Catheter specify exclusive usage with the FlowMedica Introducer Sheath.

The Boston Biomedica, Inc. (BBI) Borrelia burgdorferi IgM and IgG Western Blot Kit is an in vitro qualitative assay for the detection of IgM and IgG antibodies to Borrelia burgdorferi in human serum. It is intended for use in testing human serum samples that have been found positive or equivocal using an enzyme immunoassay (EIA) or immunofluorescence assay (FA) test procedure for B. burgdorferi antibodies.

The Boston Biomedica, Inc. (BBI) Borrelia burgdorferi IgM and IgG Western Blot Test Kit is an in vitro qualitative assay for the detection of IgM and IgG antibodies to Borrelia burgdorferi in human serum. This device is composed of the reagents, controls and test strips intended for use in Western blot testing of human serum samples for the presence of IgM and/or IgG antibodies to B. burgdorferi. The device is similar in composition to the previously approved BBI Biotech Research Laboratories Borrelia burgdorferi IgM Western Blot Test Kit. The kit also includes Blot Reading Guides, report forms and a Package Insert.

Concert™ Cranioplast is a resinous material for repair of cranial defects.

Concert™ Cranioplast is a resinous material for repair of cranial defects.

Fixation of prostheses to living bone in orthopedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, severe joint destruction secondary to trauma or other conditions and revision of previous arthroplasty.

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