NeuroBalloon™

Basic Information

• Brand Name: NeuroBalloon™
• Primary DI: 10381780035343
• Version / Model: 7CBD10
• Catalog Number: 7CBD10
• Company Name: Integra LifeSciences Switzerland Sàrl
• Labeler DUNS: 480186617
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-08
• Public Version: 6
• Public Version Date: 2023-05-15
• Public Version Status: Update
• Public Device Record Key: fd885f88-fbf8-4113-a64d-7a19f2316633

Device Description

NeuroBalloon™ NEUROBALLOON™ CATHETER

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
HAO	INSTRUMENT, SURGICAL, NON-POWERED	Neurology	882.4535	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47157	Neural-tissue balloon catheter	A sterile, flexible tube with a balloon at the distal tip used for the compression or dilation of neural tissue under direct endoscopic or fluoroscopic vision. It is inserted percutaneously over a metal stylet and typically has a small (mini) diameter with an elongated or a double (figure of 8) balloon; it is made of plastic/silicone materials and may be supplied with the stylet. It is typically used to treat trigeminal neuralgia (controlled balloon compression of the trigeminal ganglion causes selected injury to the insulation on nerve fibres which relieves pain). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M2727CBD101	HIBCC
Primary	10381780035343	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Balloon waist diameter upon inflation: 3.5 mm minimum at 0.6 ml (0.6cc) of air, 6 mm maximum at 1 ml (1cc) of air; Cath. 60cm mini. Length; for insertion into a F4 minimum (1.35mm) diameter channel

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do Not Use if Package is Damaged