Mini-Bolt Accessory Kit CMB000-AA

GUDID 00816589021608

MONTERIS MEDICAL INC

Neurological stereotactic surgery system

• Primary Device ID: 00816589021608
• NIH Device Record Key: 50914811-c801-478f-9d08-3a0e8d22fc0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mini-Bolt Accessory Kit
• Version Model Number: 21180
• Catalog Number: CMB000-AA
• Company DUNS: 021415875
• Company Name: MONTERIS MEDICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816589021608 [Primary]

FDA Product Code

• HAO: Instrument, Surgical, Non-Powered

Sterilization

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

[00816589021608]

Moist Heat or Steam Sterilization

[00816589021608]

Moist Heat or Steam Sterilization

[00816589021608]

Moist Heat or Steam Sterilization

[00816589021608]

Moist Heat or Steam Sterilization

[00816589021608]

Moist Heat or Steam Sterilization

[00816589021608]

Moist Heat or Steam Sterilization

[00816589021608]

Moist Heat or Steam Sterilization

[00816589021608]

Moist Heat or Steam Sterilization

[00816589021608]

Moist Heat or Steam Sterilization

[00816589021608]

Moist Heat or Steam Sterilization

[00816589021608]

Moist Heat or Steam Sterilization

[00816589021608]

Moist Heat or Steam Sterilization

[00816589021608]

Moist Heat or Steam Sterilization

[00816589021608]

Moist Heat or Steam Sterilization

[00816589021608]

Moist Heat or Steam Sterilization

[00816589021608]

Moist Heat or Steam Sterilization

[00816589021608]

Moist Heat or Steam Sterilization

[00816589021608]

Moist Heat or Steam Sterilization

[00816589021608]

Moist Heat or Steam Sterilization

[00816589021608]

Moist Heat or Steam Sterilization

[00816589021608]

Moist Heat or Steam Sterilization

[00816589021608]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-03
• Device Publish Date: 2026-02-23

Devices Manufactured by MONTERIS MEDICAL INC

• 00816589021608 - Mini-Bolt Accessory Kit: 2026-03-03
• 00816589021608 - Mini-Bolt Accessory Kit: 2026-03-03
• 00816589021219 - Fiducial Marker, Sterile: 2025-02-17
• 00816589021202 - Mini-Bolt System: 2024-11-20 1.6mm Mini-Bolt Accessory Kit, Refurbished
• 00816589021226 - Mini-Bolt System: 2024-08-16 Stryker Precision Targeting System - 4.5mm Drill Guide, Packaged
• 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