allay™ Nerve Cap - Large Nerve Set

Basic Information

• Brand Name: allay™ Nerve Cap - Large Nerve Set
• Primary DI: 00860012518111
• Version / Model: TL-5515-2
• Company Name: Tulavi Therapeutics, Inc.
• Labeler DUNS: 102780142
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-05
• Public Version: 3
• Public Version Date: 2025-11-19
• Public Version Status: Update
• Public Device Record Key: 6bae2748-e211-4922-b7dd-280c1a296785

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
SBG	In Situ Polymerizing Peripheral Nerve Cap	Neurology	882.5260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44814	Nerve guide, synthetic polymer, bioabsorbable	An implantable device intended to be used 1) to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve ends, 2) to encase a nerve for protection to aid in repair [e.g., to prevent ingrowth of scar tissue], or 3) for capping the end of an amputated nerve to prevent the formation of a neuroma. It is made of bioabsorbable synthetic polymer(s) in the form of a solid tube or a gel which polymerises in situ, and is designed to be chemically degraded and absorbed via natural body processes. It is also known as a nerve sheath, nerve cuff, nerve protector, nerve conduit, nerve wrap, or nerve cap.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860012518111	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius