NeuraGen®

Basic Information

• Brand Name: NeuraGen®
• Primary DI: 10381780071822
• Version / Model: PNG130
• Catalog Number: PNG-130
• Company Name: Integra Lifesciences Corporation
• Labeler DUNS: 083171244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-22
• Public Version: 7
• Public Version Date: 2024-02-22
• Public Version Status: Update
• Public Device Record Key: 205a794e-ab2e-4e5d-a370-871cc0678a48

Device Description

NeuraGen® Nerve Guide 1.5mm (ID) X 3cm (Length)

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: 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: 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
43233	Nerve guide, bioabsorbable, animal-derived	An implantable tubular device intended to be used to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve stumps. The device is typically used during hand surgery and/or nerve reconstruction. It is made of an animal-derived material (e.g., porcine-derived collagen matrix, chitosan) that can be chemically degraded and typically absorbed via natural body processes. It is also known as a nerve sheath, nerve cuff, nerve protector, nerve conduit, or a nerve wrap.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780071822	GS1
Secondary	M269PNG1301	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K011168	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1.5mm (ID) x3cm (Length)

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.