A collection of non-sterile devices intended to be given to a cochlear implant patient, typically after the first fitting, as a convenience kit of various external components of a cochlear implant system. It typically includes a cochlear implant sound proce...
A collection of sterile devices and supplies used in combination for the implantation of an embolization implant that will purposely create permanent or temporary obstruction, i.e., stop the flow of blood, in arteries/blood vessels. The kit will typically c...
A collection of prefabricated dental devices and components, which includes a dental implant, intended to be used during dental surgery and laboratory procedures to create and implant the foundation of a reconstructed tooth. In addition to the dental implan...
A collection of dedicated instruments intended to be used during heart valve repair and/or implantation of a heart valve prosthesis during an open surgical procedure. The kit typically includes two or more of the following: annulus sizers, rulers (e.g., aor...
A collection of prefabricated dental devices and components used to create a suprastructure on a dental implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory procedures and will typically consist of a di...
A collection of dedicated instruments intended to be used for the implantation of an embolization implant (implant not included). It typically includes devices for arterial access (e.g., needle, introducer, guidewires) and devices to assist introduction and...
A manually-operated, one-piece dental device intended to be used to retrieve an in situ dental implant [i.e., anchorage and/or retention (abutment) component], typically because of damage (e.g., a broken collar) or malfunction, from the oral cavity. It typi...
A collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceutic...
A collection of various sterile orthopaedic surgical instruments, dressings, and the necessary materials, which includes a pharmaceutical(s) intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic im...
A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceutica...
A collection of sterile devices intended to be used to implant an intracerebral ventricular catheter in a brain ventricle to function as a component of a ventriculo-peritoneal/atrial shunt for diversion of excessive cerebrospinal fluid (CSF) from the brain....
A collection of manual surgical instruments intended to be used during implantation of a penile prosthesis [for the treatment of erectile dysfunction (ED)]. The kit typically contains tools associated with insertion, measurement, and/or assembly of the impl...
A collection of surgical instruments and devices intended to be used for the implantation of a sacroiliac joint transarticular fixation/arthrodesis implant during a minimally-invasive procedure. It typically consists of a tray, dedicated soft-tissue protect...
A collection of non-sterile surgical instruments and devices intended to be used for the implantation of a sacroiliac joint transarticular fixation/arthrodesis implant during a minimally-invasive procedure. It typically consists of a tray, dedicated soft-ti...
A collection of non-sterile devices intended to be used with a cochlear implant system to protect the externally worn components in wet and/or rugged environments (e.g. for swimming, showering). The set typically consists of a sound processor case, waterpro...
A collection of sterile devices designed to remove the electrically-conducting leads of an implantable pacemaker or an implantable cardioverter-defibrillator (ICD), typically in cases where infection has developed or a device malfunction has occurred. It ty...
A collection of sterile tools and materials designed to repair the lead of an implantable pacemaker or an implantable cardioverter-defibrillator (ICD). Typical components include a screwdriver, wrench, screws, crimps, adhesives, sealants, and other items us...
A collection of non-sterile devices intended to be used during laparoscopic-assisted creation of a neovagina in the treatment of vaginal aplasia, whereby creation/expansion of the vaginal cavity is achieved through implantation of a tensioning thread attach...
A collection of devices intended to be used by a clinician to noninvasively adjust the operating parameters of an implanted abdominal fluid shunt pump. It consists of dedicated programming software (e.g., for installation on an off-the-shelf computer), main...
A collection of sterile devices intended to assist the surgical introduction of an implantable cardiothoracic device (e.g., implantable cardiac monitor) within a subcutaneous cavity in the thorax; it is not intended for implantation within an organ (i.e., h...
A collection of non-powered devices intended to be used by a healthcare professional in a clinical setting to assist with the activation/programming of a hearing implant system sound processor (not included). It typically includes a battery cover opener/clo...
A collection of devices designed to remove the electrically-conducting leads of an implantable pacemaker or an implantable cardioverter-defibrillator (ICD), typically in cases where infection has developed or a device malfunction has occurred. It typically ...
A collection of various implantable pacing lead caps designed to cover and protect the lead terminals of an implantable pacing device (e.g., an implanted pacemaker or defibrillator) during the implantation procedure, or to isolate (cap) any lead terminals t...
A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that include...
A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals....
A collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cut...
A collection of various sterile ophthalmic surgical instruments, dressings, and the necessary materials which includes a pharmaceutical(s) intended to be used to perform an ophthalmic surgical procedure; it is not dedicated to a specific intraocular procedu...
A collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage i...
A collection of various dental instruments designed for the surgical placement of dental implants or prostheses. It does not contain pharmaceuticals. It typically contains various dental drills (drill bits), drill extensions, depth gauges, wrenches and torq...
A collection of implantable devices used to redirect the angle of growth of long bones in paediatric patients where the growth plates (epiphysial cartilage) are not fused, to allow for the gradual correction of congenital or acquired deformities (e.g., valg...