NeuroBlate® Robotic Probe Driver

Basic Information

• Brand Name: NeuroBlate® Robotic Probe Driver
• Primary DI: 00816589020373
• Version / Model: 20772
• Catalog Number: RPD-01
• Company Name: MONTERIS MEDICAL INC
• Labeler DUNS: 021415875
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-02
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: d3e9c17f-1356-4d06-8918-d0a60b81316a

Device Description

Probe Driver - Bolt (Short)

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62269	MRI-guided laser interstitial thermal therapy system beam guide driver	A sterile robotic device intended to be used in conjunction with an MRI-guided laser interstitial thermal therapy (LITT) system to facilitate remote manoeuvring of an invasive laser beam guide during laser therapy to ablate soft-tissue brain lesions. It is noninvasively attached to the skull (typically via a stereotactic frame or an implanted skull anchor) whereby it rotates and translates a connected laser beam guide. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816589020373	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Bolt (Short)