Neurotube

Basic Information

• Brand Name: Neurotube
• Primary DI: 00844735006193
• Version / Model: GEM0420NT
• Catalog Number: 531101420011
• Company Name: SYNOVIS MICRO COMPANIES ALLIANCE, INC
• Labeler DUNS: 031284586
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-23
• Public Version: 5
• Public Version Date: 2024-08-20
• Public Version Status: Update
• Public Device Record Key: 8a77a597-d5e9-4b8b-b3bc-4808de468b54

Device Description

NEUROTUBE is designed for primary or secondary peripheral nerve repair or reconstruction. The NEUROTUBE device is resorbed through the process of hydrolysis.

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
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	00844735006193	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K983007	000

Device Sizes

Type	Value	Unit	Text
Length	20	Millimeter
Lumen/Inner Diameter	4.0	Millimeter