3.3mm Mini-Bolt VUE CMB033-V

GUDID 00816589021233

3.3mm Mini-Bolt VUE Sterile Packaged

MONTERIS MEDICAL INC

Neurological stereotactic surgery system

• Primary Device ID: 00816589021233
• NIH Device Record Key: b87228fc-d7d8-4732-8136-5b40c4fa078e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.3mm Mini-Bolt VUE
• Version Model Number: 21133
• Catalog Number: CMB033-V
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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: jhoneck@monteris.com
• Phone: +1(866)799-7655
• Email: jhoneck@monteris.com
• Phone: +1(866)799-7655
• Email: jhoneck@monteris.com
• Phone: +1(866)799-7655
• Email: jhoneck@monteris.com
• Phone: +1(866)799-7655
• Email: jhoneck@monteris.com
• Phone: +1(866)799-7655
• Email: jhoneck@monteris.com
• Phone: +1(866)799-7655
• Email: jhoneck@monteris.com
• Phone: +1(866)799-7655
• Email: jhoneck@monteris.com
• Phone: +1(866)799-7655
• Email: jhoneck@monteris.com

Device Dimensions

• Lumen/Inner Diameter: 3.3 Millimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Lumen/Inner Diameter: 3.3 Millimeter
• Lumen/Inner Diameter: 3.3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816589021233 [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: 2022-08-02
• Device Publish Date: 2022-07-25

Devices Manufactured by MONTERIS MEDICAL INC

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• 00816589021196 - Mini-Bolt System: 2024-05-28 Mini-Bolt VUE Accessory Kit
• 00816589021189 - Mini-Bolt System: 2024-03-29 VUE Extractor Tool
• 00816589021585 - Mini-Bolt System: 2024-01-10 NeuroBlate NB3 FullFire™ Diffusing Tip 1.6 Laser Probe
• 00816589021158 - Mini-Bolt System: 2023-12-28 1.6mm Mini-Bolt Accessory Kit
• 00816589021561 - Mini-Bolt System: 2023-12-28 1.6mm Mini-Bolt and Cap, Sterile Packaged
• 00816589021578 - Mini-Bolt System: 2023-12-28 1.6mm Mini-Bolt Accessory Launch Kit