Device Dossier

Neurosurgical sponges with XRD thread (Rayon) - Sponge, neuro

Device Dossier for Neurosurgical sponges with XRD thread (Rayon) - Sponge, neuro (Sponge, neuro, Class III, sponsor Life Healthcare). ARTG record,…

Intended purpose

Neurosurgical patties are indicated for use in the protection of neural tissue during surgery. They are manufactured from high performance materials and are supplied sterile. The actual size of the patty may vary slightly from the size shown on the label. All neurosurgical patties are disposable and should never be reused. The material is made of rayon.

Functional description

The medical device is a non-absorbable strung, x-ray detectable surgical sponge that is sterile and disposable. The substrate material is composed of rayon. The sponges range in size from 5mm x 8mm to 89mm x 152mm. The Neurological Sponge device has an x-ray detectable strip used to detect if a sponge has been left within the body. In addition, an ID thread is used to assist in the accounting of sponges after the surgical procedure is completed.

TGA Public Summary