Device Dossier
Retractor, general-purpose, self-retaining
Device Dossier for Retractor, general-purpose, self-retaining (Retractor, general-purpose, self-retaining, Class IIa, sponsor DePuy Synthes). ARTG…
- GMDN category: Retractor, general-purpose, self-retaining
Intended purpose
A one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. Hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. This is a reusable device.