2.2mm Mini-Bolt VUE CMB022-V

GUDID 00816589022322

2.2mm Mini-Bolt VUE Sterile Packaged

MONTERIS MEDICAL INC

Neurological stereotactic surgery system

• Primary Device ID: 00816589022322
• NIH Device Record Key: e99903df-0333-4623-a3ca-4651cbb27a5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.2mm Mini-Bolt VUE
• Version Model Number: 21122
• Catalog Number: CMB022-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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816589022322 [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

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• 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