Mini-Bolt System FFD-016

GUDID 00816589021585

NeuroBlate NB3 FullFire™ Diffusing Tip 1.6 Laser Probe

MONTERIS MEDICAL INC

MRI-guided laser interstitial thermal therapy system beam guide

• Primary Device ID: 00816589021585
• NIH Device Record Key: f2b51fbe-367c-43d8-849c-fe881698a106
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mini-Bolt System
• Version Model Number: 22002
• Catalog Number: FFD-016
• Company DUNS: 021415875
• Company Name: MONTERIS MEDICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter
• Outer Diameter: 1.6 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if package is damaged

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816589021585 [Primary]

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-10
• Device Publish Date: 2024-01-02

On-Brand Devices [Mini-Bolt System]

• 00816589021172: 3.3mm Mini-Bolt VUE Adapter
• 00816589021165: 2.2mm Mini-Bolt VUE Adapter
• 00816589021592: 1.6mm Mini-Bolt and Cap, Sterile Packaged
• 00816589021578: 1.6mm Mini-Bolt Accessory Launch Kit
• 00816589021561: 1.6mm Mini-Bolt and Cap, Sterile Packaged
• 00816589021158: 1.6mm Mini-Bolt Accessory Kit
• 00816589021585: NeuroBlate NB3 FullFire™ Diffusing Tip 1.6 Laser Probe
• 00816589021189: VUE Extractor Tool
• 00816589021196: Mini-Bolt VUE Accessory Kit
• 00816589021226: Stryker Precision Targeting System - 4.5mm Drill Guide, Packaged
• 00816589021202: 1.6mm Mini-Bolt Accessory Kit, Refurbished