The Delivery Tip system consists of a static mixer with an attached 22G blunt needle and with an additional unattached 18G blunt needle. The device is provided sterile and intended for single-use only by Rx. The Delivery Tip is indicated for use with the Dual Applicator in the allay™ Nerve Cap (TL-5515-1 and TL-5515-2) system only. The Delivery Tip is not designed, sold, or intended for use except as described by the Indication for Use.
A surgical device consisting of a fluid mixer and blunt needle intended to be attached to a dual-barrel syringe containing fluid preparation components of an implantable nerve cap agent, to mix the components and deliver the agent to the end of an amputated peripheral nerve for capping (shielding) during surgery. The nerve cap agent is intended to create physical barrier to reduce the risk of symptomatic neuroma; the syringe and nerve cap materials are not included. This is a single-use device.