Nerve Tape®

Basic Information

• Brand Name: Nerve Tape®
• Primary DI: G517NT15140
• Version / Model: NT15-14
• Catalog Number: NT15-14
• Company Name: Biocircuit Technologies, Inc.
• Labeler DUNS: 116978015
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-29
• Public Version: 2
• Public Version Date: 2024-03-13
• Public Version Status: Update
• Public Device Record Key: 72fe8aff-6991-49f7-b232-8eb5196d848e

Device Description

Nerve Tape® is a surgical implant designed to align and connect peripheral nerves. Nerve Tape® is designed to be an interface between the nerve and the surrounding tissue. Nerve Tape® is comprised of an extracellular matrix (ECM), which is fully remodeled during the healing process, and Nitinol microhooks, which bind coapted nerve ends together. When hydrated, Nerve Tape® is easy to handle, soft, pliable, nonfriable, and porous. Nerve Tape® has sufficient mechanical strength to hold the ends of the nerve together. Nerve Tape® is provided sterile, for single use only, and in a variety of sizes to meet the surgeon’s needs.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• 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
JXI	Cuff, Nerve	Neurology	882.5275	2

GMDN Terms

Code	Name	Definition	Implantable	Status
67093	Nerve guide, metal/animal-derived	An implantable sheet comprised of animal-derived bioabsorbable material(s) [e.g., porcine-derived extracellular matrix] and that includes a non-bioabsorbable metal component (metal attachment hooks) intended to be wrapped around a discontinuous peripheral nerve to form a tube for regeneration and bridging of the proximal and distal nerve stumps. The animal-derived materials are intended to be gradually replaced by host tissue during tissue remodelling while the metal hooks remain in-situ. Also known as a nerve connector, nerve sheath, nerve cuff, nerve protector, nerve conduit, or a nerve wrap, it is typically used during hand surgery and/or nerve reconstruction.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G517NT15140	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K233533	000

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	1.5	Millimeter