Южна Африка - английски - South African Health Products Regulatory Authority (SAHPRA)

dr-reddy -

Южна Африка - английски - South African Health Products Regulatory Authority (SAHPRA)

dr-reddy -

Австралия - английски - Department of Health (Therapeutic Goods Administration)

orthocentric pty ltd - 47858 - surgical instrument torque limiter - a small device designed to attach to a manual surgical instrument (e.g., a screwdriver) to define the torque effect of that tool allowing the surgeon to apply the correct torque, e.g., when tightening an orthopaedic fixation screw during a surgical intervention. it is typically made of high-grade stainless steel or synthetic materials and includes a built-in clutch mechanism. it is available in various shapes, sizes and torque ranges. it will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. this is a reusable device.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

dio australia pty ltd - 65191 - dental instrument depth limiter - instruments are intended to be used for planning, placement,maintenance and explanation of the implants from dental implant system. indicated for use is i n surgical and restorative application for placement in the bone of upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. a small device in the form of a ring or cylinder intended to be placed on a surgically-invasive dental instrument or power tool endpiece (e.g., file/rasp, drill bit, reamer) to limit the depth of insertion typically into the tooth or bone; it is typically made of polymer materials (e.g., silicone). this is a single-use device.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

zimmer biomet pty ltd - 47863 - orthopaedic implant/instrument depth limiter - an orthopaedic device designed to limit the depth of insertion of a surgical instrument (e.g., a drill or a reamer), a test device, or an device. it may be used as a stand-alone device or it may be attached to another device to control the insertion depth; this can be to prevent the insertion of an instrument or device below the surgical field of interest thereby avoiding damage to tissue behind or below the target structures. it is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of shapes and lengths. this is a reusable device

Австралия - английски - Department of Health (Therapeutic Goods Administration)

straumann pty ltd - 47863 - orthopaedic implant/instrument depth limiter - an orthopaedic device designed to limit the depth of insertion of a surgical instrument (e.g., a drill or a reamer), for try in implanting, or an implantation. it may be used as a stand-alone device or it may be attached to another device to control the insertion depth; this can be to prevent the insertion of an instrument or implantation device below the surgical field of interest thereby avoiding damage to tissue behind or below the target structures. it is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of shapes and lengths. this is a reusable device.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 47863 - orthopaedic implant/instrument depth limiter - an orthopaedic device designed to limit the depth of insertion of a surgical instrument, a trial implant, or an implant. it may be used as a stand-alone device or it may be attached to another device to control the insertion depth; this can be to prevent the insertion of an instrument or implant below the surgical field of interest thereby avoiding damage to tissue behind or below the target structures. it is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of shapes and lengths. reusable device.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 48155 - dura mater biomatrix implant - dura substitute. indicated as a dura substitute for the repair of dura mater.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

b braun australia pty ltd - 48155 - dura mater biomatrix implant - intended to be used as a dura substitute for the repair of the dura mater and replacement of connective tissue in neurosurgery. lyoplant? onlay is intended to be used as a dura substitute for the repair of the dura mater. the indication is for replacement of connective tissue in neurosurgery: - to close holes in the cerebral and cerebellar dura - for procedures to relieve increased intracranial pressure - to close holes in the spinal dura - for procedures to relieve spinal pressure

Австралия - английски - Department of Health (Therapeutic Goods Administration)

stryker australia pty ltd - 48155 - dura mater biomatrix implant - duramatrix suturable is a white, non-friable, conformable,resorbable, membrane matrix consisting of highly purified collagen derived from bovine dermis. the membrane is flexible and conforms to the contours of the defect site. the product?s mechanical strength allows the membrane matrix to be sutured in place. animal studies show that collagen dura membrane is essentially resorbed in approximately 9 months. product is supplied sterile, non-pyrogenic, in various sizes, and for single use only. duramatrix suturable is indicated as a dura substitute for the repair of dura mater.