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The NeuroPace® Burr Hole Cover is intended for use following cranial surgery to cover a 14 mm bur hole. Secondarily, the NeuroPace® Burr Hole Cover also can be used to support a 1.3 mm indwelling Jead.

The NeuroPace® Burr Hole Cover (model 8110) includes a base (also referred to as a "retainer") that is screwed to the cranium (skull) using bone screws. The cap is pressed into the base covering the opening in the base and securing a single 1.3 mm lead. The Burr Hole Cover requires three bone screws (1.5 to 1.8 mm). The screws and driver are not included in the device's packaging. The contents of the unopened, undamaged package are sterile and non-pyrogenic. The NeuroPace® Burr Hole Cover is provided sterile (for single-use only) and consists of one model / size. The device is meant to be a permanent implant. The Burr Hole Cover incorporates materials commonly found in medical devices that are known to be biocompatible. The base is made from a synthetic polymer and the cap is made from silicone. The Burr Hole Cover is MR/CT scanning compatible and is sterilized using ethylene oxide gas (EtO). The Burr Hole Cover does not include any software, incorporate any medicinal substances or contain any color additives.

The NeuroPace® Burr Hole Cover is intended for use following cranial surgery to cover a 14 mm burr hole. Secondarily, the NeuroPace Burr Hole Cover also can be used to support a 1.3 mm indwelling lead.

The NeuroPace® Burr Hole Cover (model 8110) (also referred to as "the device") includes a base (also referred to as a "retainer") that is screwed to the cranium (skull) using bone screws. The cap is an assembly comprised of a cap and a gasket. The cap is pressed into the base covering the opening in the base and securing a single 1.3 mm lead. The Burr Hole Cover requires three bone screws (1.5 to 1.8 mm). The screws and driver are not included in the device's packaging. The contents of the unopened, undamaged package are sterile and non-pyrogenic. The Burr Hole Cover is provided sterile (for single-use only) and consists of one model / size. The device is meant to be a permanent implant. The Burr Hole Cover incorporates materials commonly found in medical devices that are known to be biocompatible. The cap and base are made from a synthetic polymer and the gasket is made from silicone. The Burr Hole Cover is MR/CT scanning compatible and is sterilized using ethylene oxide gas (EtO). The Burr Hole Cover does not include any software, incorporate any medicinal substances or contain any color additives.