Mini-Bolt System CMB016-S

GUDID 00816589021561

1.6mm Mini-Bolt and Cap, Sterile Packaged

MONTERIS MEDICAL INC

Neurological stereotactic surgery system

• Primary Device ID: 00816589021561
• NIH Device Record Key: 04d114e9-ac4d-4d75-915e-53d9610195e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mini-Bolt System
• Version Model Number: 21165
• Catalog Number: CMB016-S
• 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: true
• Serial Number: false
• 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

• Lumen/Inner Diameter: 1.6 Millimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Lumen/Inner Diameter: 1.6 Millimeter
• Lumen/Inner 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816589021561 [Primary]

FDA Product Code

• HAO: INSTRUMENT, SURGICAL, NON-POWERED

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: 2023-12-28
• Device Publish Date: 2023-12-20

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