Device Dossier

Radiopaque woven surgical sponge, sterile

Device Dossier for Radiopaque woven surgical sponge, sterile (Radiopaque woven surgical sponge, sterile, Class IIa, sponsor Medline International Two).…

Intended purpose

A non-medicated sterile device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.

TGA Public Summary