Matreneu® Percutaneous Balloon Compression Kit

Basic Information

• Brand Name: Matreneu® Percutaneous Balloon Compression Kit
• Primary DI: 06939698601432
• Version / Model: PBCS-123515
• Catalog Number: PBCS-123515
• Company Name: Shenzhen Shineyard Medical Device Co.,Ltd.
• Labeler DUNS: 544919616
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-07
• Public Version: 1
• Public Version Date: 2023-06-15
• Public Version Status: New
• Public Device Record Key: 5b6f6545-f5e5-4264-98b5-2a2c1d54c01d

Device Description

This product primarily consists of five parts, i.e. the balloon catheter, puncture needle, syringe, connector, and pressure gauge.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• 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
Primary	06939698601432	GS1

Premarket Submissions

Submission Number	Supplement Number
K220920	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 86 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: – 93 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -20 – 55 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 86 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: – 93 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 55 Degrees Celsius