NeuroBlate® System NB102

GUDID 00816589021080

NeuroBlate® System

MONTERIS MEDICAL INC

MRI-guided laser interstitial thermal therapy system

• Primary Device ID: 00816589021080
• NIH Device Record Key: 56b14d71-9abd-4aaa-9d0e-b60838d064b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroBlate® System
• Version Model Number: 20980
• Catalog Number: NB102
• Company DUNS: 021415875
• Company Name: MONTERIS MEDICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)799-7655
• Email: gglaser@monteris.com
• Phone: +1(866)799-7655
• Email: gglaser@monteris.com
• Phone: +1(866)799-7655
• Email: gglaser@monteris.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816589021080 [Primary]

FDA Product Code

• GEX: Powered laser surgical instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-19
• Device Publish Date: 2018-10-17

On-Brand Devices [NeuroBlate® System]

• 00816589021097: NeuroBlate® System
• 00816589021080: NeuroBlate® System
• 00816589020656: NeuroBlate® System
• 00816589020649: NeuroBlate® System
• 00816589020632: NeuroBlate® System
• 00816589020403: NeuroBlate® System
• 00816589020311: NeuroBlate® System
• 00816589020007: NeuroBlate® System