Tulavi Therapeutics, Inc.

GUDID#

Delivery Tip - 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.
Tulavi Therapeutics, Inc.
2024-09-20
allay™ Nerve Cap - Small Nerve Set - The allay™ Nerve Cap is a nerve cap made of an absorbable polyethylene glycol implant that provides a protective layer around the end of a transected peripheral nerve. The allay™ Nerve Cap forms in situ around a nerve end inside a temporary Cap Form. The hydrogel formed is a transparent, compliant nerve cover that conforms to and provides non-constricting encasement of the nerve end. The allay™ Nerve Cap provides a protective cover around the end of the nerve during the 3-month period associated with neuroma formation , after which the hydrogel is absorbed and cleared from the site within 8 months. The allay™ Nerve Cap - Small Nerve Set (1-4 mm) is provided in a sterile, non-pyrogenic for single use only.
Tulavi Therapeutics, Inc.
2024-08-05
allay™ Nerve Cap - Large Nerve Set - The allay™ Nerve Cap is a nerve cap made of an absorbable polyethylene glycol implant that provides a protective layer around the end of a transected peripheral nerve. The allay™ Nerve Cap forms in situ around a nerve end inside a temporary Cap Form. The hydrogel formed is a transparent, compliant nerve cover that conforms to and provides non-constricting encasement of the nerve end. The allay™ Nerve Cap provides a protective cover around the end of the nerve during the 3-month period associated with neuroma formation , after which the hydrogel is absorbed and cleared from the site within 8 months. The allay™ Nerve Cap - Large Nerve Set (5-7 mm) is provided in a sterile, non-pyrogenic for single use only.
Tulavi Therapeutics, Inc.
2024-08-05
Delivery Tip - 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.
Tulavi Therapeutics, Inc.
2024-09-20