Mini-Bolt System CMB022-VA

GUDID 00816589021165

2.2mm Mini-Bolt VUE Adapter

MONTERIS MEDICAL INC

Neurological stereotactic surgery system

• Primary Device ID: 00816589021165
• NIH Device Record Key: ee09a92b-bf26-43b1-8192-2d4f7bef68e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mini-Bolt System
• Version Model Number: 21237
• Catalog Number: CMB022-VA
• Company DUNS: 021415875
• Company Name: MONTERIS MEDICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• 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: false
• OTC Over-The-Counter: false

Device Dimensions

• Lumen/Inner Diameter: 2.2 Millimeter
• Lumen/Inner Diameter: 2.2 Millimeter
• Lumen/Inner Diameter: 2.2 Millimeter
• Lumen/Inner Diameter: 2.2 Millimeter
• Lumen/Inner Diameter: 2.2 Millimeter
• Lumen/Inner Diameter: 2.2 Millimeter
• Lumen/Inner Diameter: 2.2 Millimeter
• Lumen/Inner Diameter: 2.2 Millimeter
• Lumen/Inner Diameter: 2.2 Millimeter
• Lumen/Inner Diameter: 2.2 Millimeter
• Lumen/Inner Diameter: 2.2 Millimeter
• Lumen/Inner Diameter: 2.2 Millimeter
• Lumen/Inner Diameter: 2.2 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 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816589021165 [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: 2023-09-18
• Device Publish Date: 2023-09-10

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